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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Cardinal Health Inc.: Various Prescription and OTC Medications Recalled for Temperature Exposure

Agency Publication Date: May 24, 2021
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Summary

Cardinal Health Inc. is recalling 126,679 units of various prescription and over-the-counter medications, including common brands like Synthroid (levothyroxine), Tylenol (acetaminophen), and Advair (fluticasone/salmeterol), due to temperature excursions during storage. The affected products were stored in conditions that deviated from current Good Manufacturing Practice (CGMP) requirements, potentially affecting the medications' stability or effectiveness. These products were distributed in Florida, Georgia, and South Carolina between February and March 2021. Consumers should consult their pharmacist or healthcare provider to determine if their specific medication is affected and to obtain a replacement if necessary.

Risk

Exposure to improper storage temperatures can cause certain medications to degrade or lose their potency, which may result in a patient receiving an ineffective dose or being exposed to degradation products. No specific injuries or adverse health events were reported in the recall data.

What You Should Do

  1. Check your medication packaging for the brand names and specific lot numbers listed in this recall, such as Synthroid (Lot 1138959), Tylenol Liquid Gels (all lots distributed 02/23/2021 - 03/10/2021), or Proair HFA (Lot DAF02A).
  2. If you are using a prescription medication listed in this recall, contact your doctor or pharmacist immediately for guidance and to obtain a replacement prescription; do not stop taking your medication without professional advice.
  3. For over-the-counter products like Vitamin D3, Infants' Aqueous Vitamin D, or Muro-128, check the distribution dates on your receipt or packaging to see if they were purchased between February 23, 2021, and March 10, 2021.
  4. Return any unused or affected medication to the pharmacy or retail location where it was purchased for a refund or proper disposal.
  5. Contact Cardinal Health at their Dublin, Ohio headquarters or the manufacturer listed on your medication label for further instructions regarding specific product replacements.
  6. For additional questions or to report an adverse event, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

💰Full Refund

Healthcare guidance and unused product return

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: THERAPEUTIC M 130 TABLETS
UPC Codes:
740985223680
Date Ranges: distributed 02/23/2021 through 03/10/2021
Product: NIACIN 250MG 110 TABLETS
UPC Codes:
740985228494
Date Ranges: distributed 02/23/2021 through 03/10/2021
Product: Creon (pancrelipase) Delayed-Release Capsules (36,000 USP Units) 100 Capsules
Model:
NDC 0032-3016-13
Lot Numbers:
1139494
Product: Orilissa elagolix tablets (150 mg) 28 Tablets
Model:
NDC 0074-0038-28
Lot Numbers:
1120778
Product: Norvir Ritonavir Tablets (100 mg) 30 Tablets
Model:
NDC 0074-3333-30
Lot Numbers:
1131141
Product: Synthroid (levothyroxine sodium tablets, USP) all pack sizes
Lot Numbers:
1138959
Product: METHOCARBAMOL 500MG 500 TABLETS
Model:
NDC 71093014005
Lot Numbers:
UMETA0036A
Product: FENOFIBRATE CAPSULES, UPS 67MG 100 CAPSULES
Model:
NDC 27241-118-04
Lot Numbers:
PA03410
Product: OFLOXACIN 0.3% 5ML OPTH DROPS
Model:
NDC 17478071310
Lot Numbers:
427297
Product: LIDOCAINE HCL VISC 2% 100ML SOLUTION
Model:
NDC 50383077504
Lot Numbers:
373577
Product: Atropine Sulfate Ophthalmic Solution, USP 1% 5 mL
Model:
NDC 17478-215-05
Lot Numbers:
071520A
Product: COSOPT (Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution) 10ML
Model:
NDC 174780-605-10
Lot Numbers:
430358
Product: Metoprolol Tartrate and Hydrochlorothiazide Tablets, USP 50 mg/25 mg 100 Tablets
Model:
NDC 62332-115-31
Lot Numbers:
2005005745
Product: BROMFENAC OPHTHALMIC SOLUTION 0.09% 1.7ML DROPS
Model:
NDC 62332-508-17
Lot Numbers:
AGV009
Product: Vaniqa (eflornithine hydrochloride) Cream, 13.9% 1.59 oz (45 g)
Model:
NDC 0023-4857-45
Lot Numbers:
113780
Product: UBRELVY 100MG 10UD CPLT TABLETS
Model:
NDC 23650110
Lot Numbers:
1658641
Product: RESTASIS 0.05% 30X 0.4ML OPTH PF DROPS
Model:
NDC 23916330
Lot Numbers:
T1202
Product: Linzess (linaclotide) capsules 72 mcg/capsule 30 capsules
Model:
NDC 0456-1203-30
Lot Numbers:
W04411
Product: Namzaric (memantine HCl extended release and donepezil HCl) capsules 14 mg/10 mg 30 capsules
Model:
NDC 0456-1214-30
Lot Numbers:
W04815
Product: Rectiv (nitroglycerin) Ointment 0.4% 30 g
Model:
NDC 58914-301-80
Lot Numbers:
2399070
Product: Vraylar (cariprazine) capsules all sizes/strengths
Lot Numbers:
W04494
Product: Nitrofurantoin Macrocrystals Capsules 25 mg 100 Capsules
Model:
NDC 47781-306-01
Lot Numbers:
486942
Product: BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM 4MG/1MG 30 POUCHES
Model:
NDC 47781-0356-03
Lot Numbers:
37890
Product: Oseltamivir Phosphate for Oral Suspension 6 mg/mL 60 mL
Model:
NDC 47781-384-26
Lot Numbers:
484241
Product: ERYTHROMYCIN TABLETS, USP 250MG 30
Model:
NDC 69238-1484-3
Lot Numbers:
AM200540
Product: TRAVOPROST OPHTHALMIC SOLUTION, USP 0.004% 2.5ML DROPS
Model:
NDC 60505-0593-4
Lot Numbers:
RW4409
Product: ENOXAPARIN DOFIUM INJECTION, UPD 150MG/1ML 10X1ML SYRINGES
Model:
NDC 60505-0798-4
Lot Numbers:
CV006
Product: Butorphanol Tartrate Nasal Solution USP 10 mg/mL 2.5 mL
Model:
NDC 60505-0813-1
Lot Numbers:
RT7113
Product: Timolol Maleate Ophthalmic Solution, USP 0.5% 2.5 mL
Model:
NDC 60505-1005-4
Lot Numbers:
RV7378
Product: Edarbi (azilsartan medoxomil) tablets 80 mg 30 Tablets
Model:
NDC 60631-080-30
Lot Numbers:
78902-1
Product: edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40 mg/12.5 mg 30 Tablets
Model:
NDC 60631-412-30
Lot Numbers:
78520
Product: edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40 mg/25 mg 30 Tablets
Model:
NDC 60631-425-30
Lot Numbers:
79551
Product: GEMCITABINE INJECTION 200MG/5.26ML VIAL
Model:
NDC 72485-221-02
Lot Numbers:
7T10050A
Product: Brilinta ticagrelar tablets 60 mg 60 tablets
Model:
NDC 0186-0776-60
Lot Numbers:
MP0138
Product: Bevespi Aerosphere Inhalation Aerosol 9 mcg/4.8 mcg 120 inhalations
Model:
NDC 0310-4600-12
Lot Numbers:
6030180A00
Product: xigduo XR (dapgliflozin/metformin HCl extended-release) tablets 10 mg/1000 mg 30 Tablets
Model:
NDC 0310-6280-30
Lot Numbers:
MP0077
Product: xigduo XR (dapagliflozin/metformin HCl extended-release) tablets 5 mg/1000 mg 60 Tablets
Model:
NDC 0310-6260-60
Lot Numbers:
ML0171
Product: IBUPROFEN ORAL SUSPENSION USP 100MG/5ML 120ML
Model:
NDC 59651-032-12
Lot Numbers:
BO1020069-A
Product: Eletriptan Hydrobromide Tablets 20 mg 6 Unit-dose Tablets
Model:
NDC 59651-104-69
Lot Numbers:
EA2020001-A
Product: AMOXICILLIN 500MG 100 TABLETS
Model:
NDC 65862001401
Lot Numbers:
SE5019062-A
Product: ONDANSETRON HCL 4MG 30 TABLETS
Model:
NDC 65862018730
Lot Numbers:
ON0420015-A
Product: ESZOPICLONE 3MG 100 TABLETS
Model:
NDC 65862096901
Lot Numbers:
GS0320010-A
Product: Nuedexta (dextromethorphan HBr and quinidine sulfate) Capsules 20 mg/10 mg 60 capsules
Model:
NDC 64597-301-60
Lot Numbers:
CFBFP
Product: LOTEMAX SM (loteprednol etabonate ophthalmic gel) 0.38% 5GM
Model:
NDC 24208-0507-07
Lot Numbers:
352162
Product: BENZEFOAM EMOLLIENT FOAM BENZOYL PEROXIDE 5.3% 100GM
Model:
NDC 187-0194--10
Date Ranges: distributed 02/23/2021 through 03/10/2021
Product: MURO-128 2% 15ML OPTH DROPS
Model:
NDC 324208276150
Date Ranges: distributed 02/23/2021 through 03/10/2021
Product: TOBRAMY/DEX 0.3-0.1% 10ML OPTH DROPS
Model:
NDC 24208029510
Lot Numbers:
350861
Product: DEXAMETH SOD PHOS 0.1% 5ML DROPS
Model:
NDC 24208072002
Lot Numbers:
353351
Product: Belbuca (buprenorphine hydrochloride) buccal film 300 mcg 60 pouches
Model:
NDC 59385-023-60
Lot Numbers:
37674B
Product: Belbuca (buprenorphine hydrochloride) buccal film 600 mcg 60 pouches
Model:
NDC 59385-025-60
Lot Numbers:
BL6002004
Product: SYMPROIC (NAIDEMEDINE) TABLETS 0.2MG 30 TABLETS
Model:
NDC 59385-041-30
Lot Numbers:
2003060A
Product: NURTEC ODT (RIMEGEPANT) 75MG 8 TABLETS
Model:
NDC 72618-3000-2
Lot Numbers:
4170326
Product: CATAPRES-TTS-2 ADHESIVE PATCHES
Model:
NDC 597003234
Lot Numbers:
1905666/2
Product: Spiriva HandiHaler (tiotropium bromide inhalation powder) 18 mcg
Model:
NDC 0597-0075-41
Lot Numbers:
5098
Product: ATROVENT HFA 17MCG 12.9GM INHALER
Model:
NDC 597008717
Lot Numbers:
200155
Product: Glyxambi (empagliflozin and linagliptin) Tablets 25 mg/5 mg 30 tablets
Model:
NDC 0597-0164-30
Lot Numbers:
3513
Product: Synjardy (empagliflozin and metformin hydrochloride) Tablets 12.5 mg/1000 mg 60 tablets
Model:
NDC 0597-0168-69
Lot Numbers:
C80102
Product: Jentadueto XR (linagliptin and metformin hydrochloride extended-release) Tablets 5 mg/1000 mg 30 tablets
Model:
NDC 0597-0275-33
Lot Numbers:
3189866
Product: Synjardy XR (empagliflozin and metformin hydrochloride extended-release) Tablets 25 mg/1000 mg 30 tablets
Model:
NDC 0597-0295-88
Lot Numbers:
3191432
Product: Synjardy XR (empagliflozin and metformin hydrochloride extended-release) Tablets 12.5 mg/1000 mg 60 tablets
Model:
NDC 0597-0300-45
Lot Numbers:
3190949
Product: PRAVACHOL 40MG 90 TABLETS
Model:
NDC 3519410
Lot Numbers:
ABA4203A1
Product: Valsartan Tablets USP 40 mg 30 Scored Tablets
Model:
NDC 59746-360-30
Lot Numbers:
VR120022A
Product: Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser 10 oz.
Model:
NDC 50096-502-10
Lot Numbers:
59314
Product: Meloxicam Tablets, USP 7.5 mg 100 Tablets
Model:
NDC 69097-158-07
Lot Numbers:
KA03034
Product: Nadolol Tablets, USP 40 mg 100 Tablets
Model:
NDC 69097-868-07
Lot Numbers:
NB100156
Product: CIPROFLOX/D5W 400/200 24X200ML IV SOLUTION
Model:
NDC 36000000924
Lot Numbers:
A0D0924A
Product: Prilosec (Omeprazole Magnesium) For Delayed-Release Oral Suspension 10 mg
Model:
NDC 70515-610-01
Lot Numbers:
CACU
Product: Iron 100 with Vitamin C Tablets 100 Tablets
Model:
NDC 60258-099-01
Date Ranges: distributed 02/23/2021 through 03/10/2021
Product: BENICAR 40MG 30 TABLETS
Model:
NDC 65597010430
Lot Numbers:
1703296
Product: PREGABALIN CAPSULES 300MG 90 CAPSULES
Model:
NDC 43598-298-90
Lot Numbers:
T2000309
Product: Phenobarbital Tablets, USP 32.4 mg 100 tablets
Model:
NDC 13517-111-01
Lot Numbers:
20ZHX2R
Product: Ivermectin Tablets USP 3 mg 20 Tablets
Model:
NDC 4799-806-01
Lot Numbers:
A1003273A
Product: Banzel (rufinamide) tablets 200 mg 120 tablets
Model:
NDC 62856-582-52
Lot Numbers:
80643
Product: Narcan (naloxone HCl) Nasal Spray 4 mg Two Pack
Model:
NDC 69547-353-02
Lot Numbers:
201701
Product: BROMPHENIRAMINE, PSEUDOEPHEDRINE, AND DEXTROMETHORPHAN SYRUP 473ML
Model:
NDC 71930-026-43
Lot Numbers:
13120103A
Product: Prenatal Tablets UD 100 Tablets
Model:
NDC 77333-715-10
Date Ranges: distributed 02/23/2021 through 03/10/2021
Product: cathflo activase (ALTEPLASE) 2 mg VIAL
Model:
NDC 50242-041-64
Lot Numbers:
3410425
Product: FLOVENT DISKUS 100MCG 60 INHALER
Model:
NDC 173060202
Lot Numbers:
9E9A
Product: ADVAIR HFA 45-21MCG 12GM INHALER
Model:
NDC 173071520
Lot Numbers:
TH4K
Product: ARNUITY ELLIPTA 100MCG 30INH INHALER
Model:
NDC 173087410
Lot Numbers:
F79E
Product: Arnuity Ellipta (fluticasone furoate inhalation powder) 200 mcg
Model:
NDC 0173-0876-10
Lot Numbers:
5U3D
Product: TRELEGY ELLIPTA 100-62.5-25MCG 60
Model:
NDC 0173-0893-10
Lot Numbers:
FN2J
Product: Trelegy Ellipta (fluticasone, umeclidinium, and vilanterol) 100 mcg/62.5 mcg/25 mcg
Model:
NDC 0173-0887-10
Lot Numbers:
3X8P
Product: Verapamil Hydrochloride Extended-Release Tablets USP 120 mg
Model:
NDC 68462-292-01
Lot Numbers:
19205584
Product: EZETIMIBE AND SIMVASTATIN TABLETS 10-10MG 30
Model:
NDC 68462-321-30
Lot Numbers:
17201603
Product: Theophylline (Anhydrous) Extended-Release Tablets 400 mg 100 Tablets
Model:
NDC 68462-380-01
Lot Numbers:
19205025
Product: Triumeq (abacavir, dolutegravir, and lamivudine) 600 mg/50 mg/300 mg Tablets
Model:
NDC 49702-231-13
Lot Numbers:
GS5G
Product: Hydrocortisone Ointment USP 1% 1 oz (28 g)
Model:
NDC 0472-0345-56
Date Ranges: distributed 02/23/2021 through 03/10/2021
Product: FaBB Multivitamin Supplement 100 Tablets
Date Ranges: distributed 02/23/2021 through 03/10/2021
Product: bupropion Hydrochloride Tablets, USP 75 mg 100 Tablets
Model:
NDC 23155-191-01
Lot Numbers:
L200791
Product: AcetaZOLAMIDE Tablets, USP 125 mg 100 Tablets
Model:
NDC 23155-287-01
Lot Numbers:
M200833
Product: Calcium Acetate Capsules 667 mg 200 Capsules
Model:
NDC 23155-531-02
Lot Numbers:
L200801
Product: LITHIUM CARB 150MG 100 CAPSULES
Model:
NDC 54252625
Lot Numbers:
AB1024A
Product: LEUCOVORIN 15MG 24 TABLETS
Model:
NDC 54449810
Lot Numbers:
064159A
Product: Levofloxacin Injection in 5% Dextrose 500 mg 100 mL
Model:
NDC 0143-9721-24
Lot Numbers:
2007046.1
Product: TIROSINT (levothyroxine sodium) capsules 175MCG
Model:
NDC 71858-0055-4
Lot Numbers:
200606
Product: Enbrace HR 30 ct. Softgels Enhanced Prenatal Vitamin
Model:
NDC 64661-650-30
Date Ranges: distributed 02/23/2021 through 03/10/2021
Product: Tylenol Acetaminophen Regular Strength Liquid Gels 20 ct (325 mg)
Model:
NDC 50580-487-20
Date Ranges: distributed 02/23/2021 through 03/10/2021
Product: INVEGA SUSTENNA 156MG/1ML SYRINGES
Model:
NDC 50458056301
Lot Numbers:
KIB0M00
Product: Auryxia (ferric citrate) tablets 210 mg 200 Tablets
Model:
NDC 59922-631-01
Lot Numbers:
AN0142D
Product: Livalo (pitavastatin) tablets 2 mg
Model:
NDC 66869-204-90
Lot Numbers:
3193479
Product: PHENTERMINE HCL 30MG 100 CAPSULES
Model:
NDC 10702002801
Lot Numbers:
16667A
Product: PHENTERMINE HCL 37.5MG 100 CAPSULES
Model:
NDC 10702002901
Lot Numbers:
16649A
Product: Infants Aqueous Vitamin D Oral Drops 400 IU/mL 50 mL
Date Ranges: distributed 02/23/2021 through 03/10/2021
Product: Ferrous Sulfate 75 mg Drops 50 mL
Model:
NDC 54838-011-50
Date Ranges: distributed 02/23/2021 through 03/10/2021
Product: SILADRYL 12.5/5ML 118ML LIQUID
Model:
NDC 354838135404
Date Ranges: distributed 02/23/2021 through 03/10/2021
Product: Pantoprazole Sodium Delayed-Release Tablets, USP 20 mg 90 Tablets
Model:
NDC 62175-180-46
Lot Numbers:
20249489A
Product: NOHIST-DM Antihistamine/Antitussive Nasal Decongestant 16 fl. oz.
Model:
NDC 68047-186-16
Date Ranges: distributed 02/23/2021 through 03/10/2021
Product: TRI-LO-MARZIA TABLETS 3X28 BPK
Model:
NDC 68180-837-73
Lot Numbers:
L001911
Product: Amlodipine and Olmesartan Medoxomil Tablets 10 mg/20 mg 30 Tablets
Model:
NDC 33342-192-07
Lot Numbers:
BAD62005A
Product: TRAZODONE HYDROCHLORIDE TABLETS, USP 50MG 100 TABLET
Model:
NDC 0904-6868-61
Lot Numbers:
R01580
Product: MICONAZOLE 7 2% 45GM CREAM
Model:
NDC 009047734459
Date Ranges: distributed 02/23/2021 through 03/10/2021
Product: Banophen Diphenhydramine HCl 25 mg 100 capsules
Model:
NDC 0904-5306-60
Date Ranges: distributed 02/23/2021 through 03/10/2021
Product: Acne Medication Benzoyl Peroxide Gel USP, 5% 1.5 oz
Model:
NDC 0536-1055-56
Date Ranges: distributed 02/23/2021 through 03/10/2021
Product: VITAMIN D3 50MCG 100 SOFTGELS
Model:
NDC 880681009000
Date Ranges: distributed 02/23/2021 through 03/10/2021
Product: VITAMIN D3 25MCG 90 TABLETS
Model:
NDC 880681168004
Date Ranges: distributed 02/23/2021 through 03/10/2021
Product: VITAMIN D3 25MCG 180 TABLETS
Model:
NDC 880681168011
Date Ranges: distributed 02/23/2021 through 03/10/2021
Product: DIBUCAINE TOPICAL ANESTHETIC 1% OINTMENT 28GM
Model:
NDC 0536-1211-95
Date Ranges: distributed 02/23/2021 through 03/10/2021
Product: BENZOYL PEROXIDE WASH 5% 148ML
Model:
NDC 0536-1259-63
Date Ranges: distributed 02/23/2021 through 03/10/2021
Product: VITAMIN D3 50MCG 100 CALC TABLETS
Model:
NDC 880681170007
Date Ranges: distributed 02/23/2021 through 03/10/2021
Product: CARBIDOPA AND LEVORDOPA TABLETS, USP 25MG/100MG 100 TABLETS
Model:
NDC 51862-856-01
Lot Numbers:
FG12532
Product: PEDIA-LAX 66ML ENEMA
Model:
NDC 301320202205
Date Ranges: distributed 02/23/2021 through 03/10/2021
Product: Belsomra (suvorexant) tablets 10 mg 30 Tablets
Model:
NDC 00006-0033-30
Lot Numbers:
1791139
Product: Belsomra (suvorexant) tablets 20 mg 30 Tablets
Model:
NDC 0006-0335-30
Lot Numbers:
1778598
Product: Steglatro (ertugliflozin) tablets 15 mg 30 Tablets
Model:
NDC 0006-5364-03
Lot Numbers:
T013566
Product: ASMANEX TWST 220MCG 60INH PWD INHALER
Model:
NDC 85134102
Lot Numbers:
T023471
Product: Levothyroxine Sodium Tablets, USP 125 mcg 90 Tablets
Model:
NDC 0378-1813-77
Lot Numbers:
3109046
Product: Estradiol Transdermal System, USP 0.1 mg/day
Model:
NDC 0378-4623-26
Lot Numbers:
3108206
Product: Epinephrine Injection, USP Auto-Injectors (All strengths/packs)
Model:
9502-500-01
49502-500-02
49502-500-92
49502-501-01
Lot Numbers:
0FM544
Product: Proctofoam HC (hydrocortisone and pramoxine) topical aerosol 10 g
Model:
NDC 0037-6822-10
Lot Numbers:
33119
Product: NAT B VIT D3 2000U 100 TABLETS
Model:
NDC 079854041125
Date Ranges: distributed 02/23/2021 through 03/10/2021
Product: Vitamin D3 Cholecalciferol 50,000 IU 100 Capsules
Model:
NDC 75834-020-01
Date Ranges: distributed 02/23/2021 through 03/10/2021
Product: Vitamin D3 Cholecalciferol 50,000 IU 12 Capsules
Model:
NDC 75834-020-12
Date Ranges: distributed 02/23/2021 through 03/10/2021
Product: TOBREX 0.3% 3.5GM OPTH OINTMENT
Model:
NDC 65064435
Lot Numbers:
20B14E
Product: Ilevro (nepafenac ophthalmic suspension) 0.3% 3 mL
Model:
NDC 0065-1750-14
Lot Numbers:
10CPE
Product: CIPRODEX (CIPROFLOXACIN 0.3 AND DEXAMETHASONE 0.1%) 7.5ML DROPS
Model:
NDC 0078-0799-75
Lot Numbers:
20F02UA
Product: Rybelsus (semaglutide) Tablets 7 mg 30 tablets
Model:
NDC 0169-4307-13
Lot Numbers:
K082347
Product: Benztropine Mesylate Tablets, USP all sizes/strengths
Lot Numbers:
S2008031
Product: Lamotrigine Extended-Release Tablets 250 mg 30 Tablets
Model:
NDC 49884-604-11
Lot Numbers:
10116
Product: ZOLPIDEM TARTRATE SUBLINGUAL TABLET 3.5 MG 30 POUCHES
Model:
NDC 49884089911
Lot Numbers:
12699501
Product: HySept Solution 0.25% Sodium Hypochlorite Solution 473 mL
Model:
NDC 39328-063-25
Date Ranges: distributed 02/23/2021 through 03/10/2021
Product: RISPERIDONE 1MG/ML 30ML SOLUTION
Model:
NDC 50458059601
Lot Numbers:
KHB2701
Product: Benzoyl Peroxide 2.5% Acne Treatment Gel 2.1 oz
Model:
NDC 45802-101-96
Date Ranges: distributed 02/23/2021 through 03/10/2021
Product: Benzoyl Peroxide 10% Acne Medication Wash 5 oz
Model:
NDC 45802-318-01
Date Ranges: distributed 02/23/2021 through 03/10/2021
Product: Polyethylene Glycol 3350 Powder Laxative 4.1 oz
Model:
NDC 45802-868-01
Date Ranges: distributed 02/23/2021 through 03/10/2021
Product: POLYETHYLENE GLYCOL 3350 Laxative 14 Packets
Model:
NDC 45802-868-66
Date Ranges: distributed 02/23/2021 through 03/10/2021
Product: Fexofenadine Hydrochloride Tablets, 180 mg 100 Tablets
Model:
NDC 45802-571-78
Date Ranges: distributed 02/23/2021 through 03/10/2021
Product: LORATADINE 10MG 100 TABLETS
Model:
NDC 345802650788
Date Ranges: distributed 02/23/2021 through 03/10/2021
Product: Cetirizine Hydrochloride Tablets, 10 mg 300 Count
Model:
NDC 345802919878
Date Ranges: distributed 02/23/2021 through 03/10/2021
Product: Podofilox Topical Solution 0.5% 3.5ML
Model:
NDC 0574-0611-05
Lot Numbers:
402995
Product: HYDROCORTISONE ACET 30MG 12 SUPPOSITORY
Model:
NDC 0574-7093-12
Lot Numbers:
433202
Product: Triamcinolone Acetonide Ointment, USP, 0.025% 80g
Model:
NDC 45802-054-36
Lot Numbers:
0MT0286
Product: LYRICA (pregabalin) capsules, 200mg 90-count
Lot Numbers:
CK1081
Product: Methotrexate Injection, USP 50 mg/2mL VIAL
Model:
NDC 61703-350-38
Lot Numbers:
H074437AA
Product: Chantix (varenicline) Tablets Continuing Month Box (1 mg)
Model:
NDC 0069-0469-03
Lot Numbers:
EC5910
Product: Chantix (varenicline) Tablets Continuing Month Box 56 tablets
Model:
NDC 0069-0469-56
Lot Numbers:
EM1069
Product: Chantix (varenicline) Tablets Starting Pack
Model:
NDC 0069-0471-03
Lot Numbers:
EC5911
Product: LEVOXYL Tablets, USD, 150MCG 100-count
Model:
NDC 60793-858-01
Lot Numbers:
20D27
Product: PROMETHAZINE PLAIN ORAL SOLUTION 6.25MG/5ML 473ML
Model:
NDC 0211-0927-16
Lot Numbers:
20001481
Product: Absorbable Calcium 1200 mg plus D3 5000 IU 120 Softgels
UPC Codes:
840093100672
Date Ranges: distributed 02/23/2021 through 03/10/2021
Product: Intrarosa Prasterone Vaginal Inserts 6.5 mg 28 ct
Model:
NDC 64011-601-28
Lot Numbers:
R81339
Product: Budesonide and Formoterol Fumarate Inhalation Aerosol 80/4.5 120 inhalations
Model:
NDC 0310-7372-20
Lot Numbers:
2000655C00
Product: Medroxyprogesterone acetate injectable suspension, USP 150 mg/mL Prefilled Syringe
Model:
NDC 59762-4538-2
Lot Numbers:
EC4744
Product: medroxyprogesterone acetate injectable suspension, USP 150MG/ML
Model:
NDC 59762-4538-02
Lot Numbers:
DN0428
Product: Cefazolin for Injection, USP 1 gram vial
Model:
NDC 0781-3451-70
Lot Numbers:
JZ9830
Product: HYDROCORTISONE 1% 30gm cream
Lot Numbers:
KK4912
Product: TUBERSOL (Tuberculin Purified Protein Derivative) 5 US Units
Model:
NDC 49281-752-21
Lot Numbers:
C5804AA
Product: Collagenase Santyl Ointment 250 units/g 30 grams
Model:
NDC 50484-010-30
Lot Numbers:
191960
Product: CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP 150MG 100-count
Model:
NDC 63304-692-01
Lot Numbers:
AB77104
Product: COREG CR (carvedilol phosphate) Extended Release Capsules 80 mg
UPC Codes:
57664066683
Lot Numbers:
P0978
Product: Trokendi XR (topiramate) extended-release capsules 100 mg 30 Capsules
Model:
NDC 17772-103-30
Lot Numbers:
1741214
Product: Colcrys (colchicine, USP) tablets 0.6 mg 30 tablets
Model:
NDC 64764-119-07
Lot Numbers:
11888415
Product: Children's Loratadine Oral Solution USP 5 mg/5 mL 4 FL OZ
Model:
NDC 51672-2131-8
Date Ranges: distributed 02/23/2021 through 03/10/2021
Product: Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg 8.5 g
Model:
NDC 59310-579-22
Lot Numbers:
DAF02A
Product: NEOMYCIN SULF TABLETS, USP 500mg 100-count
Model:
NDC: 0093-1177-01
Lot Numbers:
3006910
Product: BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLETS 2.5 mg/6.25 mg 100-count
Model:
NDC 0093-3241-01
Lot Numbers:
1417295A
Product: PENICILLIN V POT for Oral Solution, USP 125mg/5mL 100mL
Model:
NDC 0093-4125-73
Lot Numbers:
35446365A
Product: EPINEPHRINE INJECTION USP 0.3MG (AUTO-INJECTORS) 2-pack
Model:
NDC 0093-5986-27
Lot Numbers:
033J20AA
Product: EPINEPHRINE INJECTION USP 0.15 MG (AUTO-INJECTORS) 2-pack
Model:
NDC 0093-5985-27
Lot Numbers:
025C20AA
Product: Balziva 28 Day (norethindrone and ethinyl estradiol tablets USP) 6 dispensers
Model:
NDC 0555-9034-58
Lot Numbers:
100016785
Product: Levalbuterol tartrate HFA Inhalation Aerosol 45 mcg 15 g
Model:
NDC 0591-2927-54
Lot Numbers:
200093
Product: Desvenlafaxine Extended-Release Tablets 25 mg 30 Tablets
Model:
NDC 0591-4060-30
Lot Numbers:
1399650A
Product: Sulindac Tablets, USP 200mg 100-count
Model:
NDC 42806-011-01
Lot Numbers:
1578F201
Product: Darifenacin Extended-release Tablets 7.5 mg 30 Tablets
Model:
NDC 13668-202-30
Lot Numbers:
BDZ7G005
Product: Darifenacin Extended-release Tablets 15 mg 30 Tablets
Model:
NDC 13668-203-30
Lot Numbers:
BDZ9G005
Product: Folivane-Plus Capsule Vitamin Supplement 90 ct
Model:
NDC 13811-539-90
Date Ranges: distributed 02/23/2021 through 03/10/2021
Product: TRAMADOL HYDROCHLORIDE TABLETS USP 100MG 100-count
Model:
NDC 52817-0196-10
Lot Numbers:
200340H1
Product: Restora Omega-3 Lactobacillus Casei 30 Capsules
Model:
NDC 52747-200-30
Date Ranges: distributed 02/23/2021 through 03/10/2021
Product: INTEGRA 325/40/3mg 90-count bottle
Model:
NDC 52747-710-60
Date Ranges: distributed 02/23/2021 through 03/10/2021
Product: VIMPAT (lacosamide) Tablets 100 mg 60-count
Lot Numbers:
912056
Product: VIMPAT (lacosamide) Tablets 200mg 60-count
Model:
NDC 0131-2480-35
Lot Numbers:
912064
Product: Briviact (brivaracetam) tablets 50 mg 60-count
Model:
NDC 50474-570-66
Lot Numbers:
309750
Product: Amantadine Hydrochloride Tablets 100 mg 100-count
Model:
NDC 0832-0111-00
Lot Numbers:
395310
Product: HALOPERIDOL TABLETS 20mg, USP 100-count
Model:
NDC 0832-1560-11
Lot Numbers:
2007346C
Product: Corgard (nadolol tablets, USP) 40 mg 100 Tablets
Model:
NDC 27505-101-01
Lot Numbers:
19T28
Product: CYANOCOBAL Injection 1000MCG/ML VIAL
Model:
NDC 69680-112-25
Lot Numbers:
303824
Product: Brompheniramine, Pseudoephedrine and Dextromethorphan Syrup 473 mL
Model:
NDC 60432-275-16
Lot Numbers:
UV1092
Product: Enalapril Maleate Tablets, USP 2.5 mg 100 tablets
Model:
NDC 64679-923-02
Lot Numbers:
DV10467

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87512
Status: Resolved
Manufacturer: Cardinal Health Inc.
Sold By: Cardinal Health; pharmacies; hospitals; healthcare facilities
Manufactured In: United States, Germany, Canada, India, Puerto Rico, Austria, Singapore, Ireland
Units Affected: 198 products (55 bottles; 4 bottles; 1669 bottles; 210 cartons; 362 bottles; 123 bottles; 51 bottles; 106 BOXES; 339 bottles; 240 bottles; 424 bottles; 12 bottles; 71 bottles; 152 CARTON; 72 tubes; 964 bottles; 3688 bottles; 1529 bottles; 659 bottles; 31 tubes; 759 bottles; 15 bottles; 249 CARTONS; 15885 bottles; 135 CARTON; 325 CARTONS; 64 BOXES; 38 bottles; 31 droptainers; 328 bottles; 244 bottles; 273 bottles; 3 CARTON; 1278 bottles; 355 inhalers; 664 bottles; 378 bottles; 345 CARTONS; 20 CARTONS; 373 bottles; 1935 bottles; 29 bottles; 255 bottles; 463 boxes; 2 carton; 64 droptainers; 47 droptainers; 318 droptainers; 96 cartons; 47 cartons; 67 BOXES; 1240 CARTON; 17 patches; 2611 inhalers; 667 inhalers; 592 bottles; 284 bottles; 52 bottles; 269 bottles; 751 bottles; 3 bottles; 20 bottles; 16 tubes; 576 bottles; 40 bottles; 40 bags; 13 packets; 1 bottle; 75 bottles; 6 CONTAINERS; 1 bottle; 504 cartons; 30 bottles; 11189 plungers; 73 carton; 41 bottles; 1473 vials; 237 inhalers; 297 inhalers; 513 inhalers; 353 inhalers; 4065 CARTON; 903 inhalers; 513 bottles; 7 CARTON; 141 bottles; 2264 bottles; 23 tubes; 54 bottles; 32 bottles; 122 bottles; 35 bottles; 298 bottles; 12 bottles; 35 bags; 25 boxes; 11 bottles; 37 bottles; 534 syringes; 136 bottles; 453 bottles; 16 bottles; 237 bottles; 422 bottles; 357 bottles; 78 bottles; 4 bottles; 24 bottles; 60 CARTON; 33 bottles; 91 CARTON; 71 tubes; 88 bottles; 189 tubes; 380 BOTTLE; 53 BOTTLE; 19 BOTTLE; 701 CARTON; 37 BOTTLE; 427 BOTTLE; 407 BOXES; 147; 119 cartons; 299 cartons; 215 bottles; 122 inhalers; 112 bottles; 72 cartons; 620 injector; 834 aerosol containers; 47 bottles; 523 bottles; 205 bottles; 28 tubes; 348 droptainers; 341 CARTON; 1189 cartons; 60 bottles; 131 bottles; 55 Boxes; 236 bottles; 39 bottles; 5 tubes; 31 bottles; 163 bottles; 934 boxes; 321 bottles; 2854 bottles; 1371 bottles; 180 bottles; 95 suppositories; 178 tubes; 49 bottles; 341 vials; 940 cartons; 848 bottles; 1040 cartons; 13 bottles; 49 CARTON; 8 bottles; 205 cartons; 905 inhalers; 286 syringes; 148 syringes; 8 vials; 143 tubes; 406 vials; 1391 tubes; 223 bottles; 133 bottles; 490 bottles; 160 bottles; 2907 bottles; 26895 inhalers; 41 bottles; 235 bottles; 91 bottles; 414 boxes; 1776 boxes; 23 bottles; 828 inhalers; 57 bottles; 92 bottles; 52 bottles; 37 bottles; 80 bottles; 86 BOTTLE; 31 cartons; 32 bottles; 796 bottles; 882 bottles; 101 bottles; 271 bottles; 35 BOTTLE; 2 bottles; 6 boxes; 15 bottles; 10 bottles)
Distributed To: Florida, Georgia, South Carolina

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.