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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

SterRx Sterile Injectable Drugs Recalled for Sterility Concerns

Agency Publication Date: December 29, 2021
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Summary

SterRx, LLC is recalling 587,407 bags of various sterile injectable medications because the company cannot guarantee the sterility of the products. The recall includes several critical medications such as Midazolam, Morphine Sulfate, Epinephrine, and Fentanyl Citrate. These products were distributed nationwide to hospitals and healthcare facilities for clinical use. No injuries or illnesses have been reported to date, but a lack of sterility assurance in injectable drugs poses a significant risk to patient safety.

Risk

Injectable medications that are not guaranteed to be sterile can cause life-threatening infections, sepsis, or other serious health complications when administered to patients. This is especially dangerous for patients in hospital settings who may already have weakened immune systems.

What You Should Do

  1. This recall affects 587,407 bags of various sterile injectable medications sold under the SterRx brand, including Diltiazem HCl, Epinephrine, Fentanyl Citrate, Midazolam, Morphine Sulfate, Norepinephrine, Phenylephrine HCl, Sodium Bicarbonate, and Succinylcholine Chloride.
  2. Identify the affected products by checking the label for the 'SterRx' brand name and the National Drug Code (NDC) and lot numbers printed on the medication bag. See the Affected Products section below for the full list of affected codes.
  3. Hospital staff, pharmacists, and healthcare providers should immediately stop using and quarantine any remaining stock of the recalled medications.
  4. Contact SterRx, LLC directly or your distributor to arrange for the return of the affected products.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: dilTIAZem HCl in 5% Dextrose Injection (125 mg per 125 mL)
Variants: 32 mcg per mL, Rx only
Lot Numbers:
S21200/BVC (15-Nov-21)
S21296/BYM (19-Dec-21)
S21320/BZG (4-Jan-22)
S21164/BTV (3-Dec-21)
S21191/BUU (18-Dec-21)
S21197/BUZ (31-Dec-21)
S21220/BVV (13-Jan-22)
S21271/BXO (27-Jan-22)
S21272/BXP (28-Jan-22)
S21299/BYP (18-Feb-22)
S21300/BYQ (19-Feb-22)
NDC:
70324-951-01

Quantity: 8,946 bags

Product: Fentanyl Citrate in 0.9% Sodium Chloride Injection (1 mg per 100 mL)
Variants: 10 mcg per mL, Rx only
Lot Numbers:
S21349/CAI (23-Mar-22)
S21356/CAP (1-Apr-22)
S21361/CAU (2-Apr-22)
NDC:
70324-327-01

Quantity: 10,660 bags

Product: Fentanyl Citrate in 0.9% Sodium Chloride Injection (2.5 mg per 250 mL)
Variants: 10 mcg per mL, Rx only
Lot Numbers:
S21353/CAM (26-Mar-22)
S21358/CAR (30-Mar-22)
S21364/CAX (6-Apr-22)
NDC:
70324-327-02

Quantity: 5,000 bags

Product: MORPHINE SULFATE in 0.9% Sodium Chloride Injection (50 mg per 50 mL)
Variants: 1 mg per mL, Rx only
Lot Numbers:
S21292/BYI
NDC:
70324-427-01

Quantity: 880 bags

Product: NOREPINEPHRINE in 5% Dextrose Injection (16 mg per 250 mL)
Variants: 64 mcg per mL, Rx only
Lot Numbers:
S21194/CDW
NDC:
70324-002-01

Quantity: 1,044 bags

Product: NOREPINEPHRINE in 0.9% Sodium Chloride Injection (4 mg per 250 mL)
Variants: 18 mcg per mL, Rx only
Lot Numbers:
S20415/BKY (12-Nov-21)
S20418/BLB (13-Nov-21)
S20452/BMI (5-Dec-21)
S20463/BMT (9-Dec-21)
S20464/BMU (18-Dec-21)
S20478/BNF (23-Dec-21)
S21021/BOI (6-Jan-22)
S21033/BOU (20-Jan-22)
S21047/BPH (21-Jan-22)
S21059/BPU (28-Jan-22)
S21094/BRE (18-Feb-22)
S21117/BSB (3-Mar-22)
S21118/BSC (10-Mar-22)
S21138/BSW (17-Mar-22)
S21227/BWA (7-May-22)
S21239/BWK (12-May-22)
S21279/BXW (5-Jun-22)
S21295/BYL (16-Jun-22)
S21298/BYO (18-Jun-22)
S21339/BZZ (16-Jul-22)
S21346/CAF (21-Jul-22)
S21355/CAO (28-Jul-22)
S21370/CBD (4-Aug-22)
S21372/CBF (7-Aug-22)
S21438/CDS (4-Sep-22)
NDC:
70324-651-01

Quantity: 121,584 bags

Product: Morphine Sulfate in 5% Dextrose Injection (100 mg per 100 mL)
Variants: 1 mg per mL, Rx only
Lot Numbers:
S21293/BYJ
NDC:
70324-452-01

Quantity: 40 bags

Product: NOREPINEPHRINE in 5% Dextrose Injection (8 mg per 250 mL)
Variants: 32 mg per mL, Rx only
Lot Numbers:
S21409/CCR
NDC:
70324-476-01

Quantity: 1,428 bags

Product: Midazolam in 0.9% Sodium Chloride Injection (50 mg per 50 mL)
Variants: 1 mg per mL, Rx only
Lot Numbers:
S21131/BSP (10-Nov-21)
S21132/BSQ (11-Nov-21)
S21139/BSX (18-Nov-21)
S21150/BTI (24-Nov-21)
S21158/BTP (1-Dec-21)
S21160/BTR (2-Dec-21)
S21170/BUB (9-Dec-21)
NDC:
70324-102-01

Quantity: 15,660 bags

Product: Morphine Sulfate in 0.9% Sodium Chloride Injection (100 mg per 100 mL)
Variants: 1 mg per mL, Rx only
Lot Numbers:
S21317/BZE
NDC:
70324-427-02

Quantity: 880 units

Product: dilTIAZem HCl in 0.7% Sodium Chloride Injection (125 mg per 125 mL)
Variants: 1 mg per mL, Rx only
Lot Numbers:
S21164/BTV (3-Dec-21)
S21191/BUU (18-DEC-21)
S21197/BUZ (31-Dec-21)
S21220/BVV (13-Jan-22)
S21271/BX0 (27-Jan-22)
S21272/BXP (28-Jan-22)
S21299/BYP (18-Fev-22)
S21300/BYQ (19-Feb-22)
NDC:
70324-976-01

Quantity: 24,300 bags

Product: NOREPINEPHRINE in 5% Dextrose Injection (4 mg per 250 mL)
Variants: 16 mcg per mL, Rx only
Lot Numbers:
S21192/BUV (18-Apr-22)
S21205/BVH (23-Apr-22)
S21402/CCK (21-Aug-22)
NDC:
70324-451-01

Quantity: 9,360 bags

Product: EPINEPHrine in 0.9% Sodium Chloride Injection (2 mg per 250 mL)
Variants: 8 mcg per mL, Rx only
Lot Numbers:
S21257/BXC
NDC:
70324-027-01

Quantity: 2,779 bags

Product: PHENYLepherine HCL in 0.9% Sodium Chloride (20 mg per 250 mL)
Variants: 80 mcg per mL, Rx only
Lot Numbers:
S21086/BQW (14-Dec-21)
S21149/BTH (23-Jan-22)
S21159/BTQ (30-Jan-22)
S21265/BXI (3-Apr-22)
S21305/BYU (24-Apr-22)
S21311/BZA (26-Apr-22)
NDC:
70324-701-01

Quantity: 18,948 bags

Product: Sodium Bicarbonate in 5% Dextrose Injection (150 mEq per 1000 mL)
Variants: 12.6 mg per mL, Rx only
Lot Numbers (77):
S20483/BNJ (23-Nov-21)
S20484/BNK (24-Nov-21)
S20485/BNL (25-Nov-21)
S21008/BNV (3-Dec-21)
S21010/BNX (9-Dec-21)
S21025/BOM (10-Dec-21)
S21026/BON (15-Dec-21)
S21027/BOO (16-Dec-21)
S21035/BOW (17-Dec-21)
S21045/BPF (18-Dec-21)
S21046/BPG (21-Dec-21)
S21050/BPK (22-Dec-21)
S21054/BPO (24-Dec-21)
S21055/BPQ (25-Dec-21)
S21061/BPW (28-Dec-21)
S21062/BPX (29-Dec-21)
S21063/BPY (30-Dec-21)
S21064/BPZ (31-Dec-21)
S21069/BQE (31-Dec-21)
S21073/BQI (4-Jan-22)
S21074/BQJ (5-Jan-22)
S21076/BQL (6-Jan-22)
S21077/BQM (7-Jan-22)
S21081/BQQ (20-Jan-22)
S21083/BQS (22-Jan-22)
S21084/BQT (25-Jan-22)
S21110/BRU (26-Jan-22)
S21111/BRV (27-Jan-22)
S21112/BRW (27-Jan-22)
S21113/BRX (28-Jan-22)
S21114/BRY (1-Feb-22)
S21115/BRZ (1-Feb-22)
S21123/BSH (2-Feb-22)
S21124/BSI (3-Feb-22)
S21126/BSK (3-Feb-22)
S21127/BSL (4-Feb-22)
S21128/BSM (4-Feb-22)
S21129/BSN (5-Feb-22)
S21168/BTZ (10-Mar-22)
S21169/BUA (11-Mar-22)
S21176/BUH (15-Mar-22)
S21181/BUL (17-Mar-22)
S21182/BUM (17-Mar-22)
S21270/BXN (26-May-22)
S21274/BXR (26-May-22)
S21321/BZH (1-Jun-22)
S21322/BZI (2-Jun-22)
S21323/BZJ (3-Jun-22)
S21324/BZK (3-Jun-22)
S21325/BZL (7-Jun-22)
NDC:
70324-326-01

Quantity: 127,260 bags

Product: Succinylcholine Chloride Injection (1,000 mL)
Variants: 200 mg per 10 mL, 20 mg per mL, Rx only
Lot Numbers:
S21367/CBA (18-Nov-21)
S21403/CCL (9-Dec-21)
NDC:
70324-826-01

Quantity: 3,540 bags

Product: EPINEPHIrine in 0.9% Sodium Chloride Injection (4 mg per 250 mL)
Variants: 16 mcg per mL, Rx only
Lot Numbers:
S21254/BWZ (22-Nov-21)
S21263/BXG (30-Nov-21)
S21333/BZT (11-Jan-22)
S21398/CCG (19-Feb-22)
NDC:
70324-227-01

Quantity: 26,928 bags

Product: EPINEPHIrine in 0.9% Sodium Chloride Injection (5 mg per 250 mL)
Variants: 20 mcg per mL, Rx only
Lot Numbers:
S21255/BXA (22-Jan-22)
S21264/BXH (29-Jan-22)
S21328/BZO (10-Mar-22)
NDC:
70324-052-01

Quantity: 7,548 bags

Product: EPINEPHIrine in 0.9% Sodium Chloride Injection (8 mg per 250 mL)
Variants: 32 mcg per mL, Rx only
Lot Numbers:
S21255/BXA (22-Jan-22)
S21264/BXH (29-Jan-22)
S21328/BZO (10-Mar-22)
NDC:
70324-077-01

Quantity: 5,832 bags

Product: EPINEPHrine in 0.9% Sodium Chloride Injection (16 mg per 250 mL)
Variants: 64 mcg per mL, Rx only
Lot Numbers:
S21335/BZV
NDC:
70324-627-01

Quantity: 684 bags

Product: Midazolam in 0.9% Sodium Chloride Injection (100 mg per 100 mL)
Variants: 1 mg per mL, Rx only
Lot Numbers:
S21065/BQA (12-Nov-21)
S21066/BQB (19-Nov-21)
S21142/BTA (19-Nov-21)
S21143/BTB (20-Nov-21)
S21146/BTE (21-Nov-21)
S21147/BTF (25-Nov-21)
S21148/BTG (25-Nov-21)
S21153/BTL (26-Nov-21)
S21154/BTM (27-Nov-21)
S21171/BUC (10-Dec-21)
S21172/BUD (11-Dec-21)
S21173/BUE (15-Dec-21)
S21190/BUT (16-Dec-21)
S21201/BVD (22-Dec-21)
S21202/BVE (24-Dec-21)
S21203/BVF (29-Dec-21)
S21204/BVG (19-Jan-22)
S21258/BXD (20-Jan-22)
S21275/BXS (30-Jan-22)
S21276/BXT (2-Feb-22)
S21277/BXU (3-Feb-22)
S21278/BXV (3-Feb-22)
S21284/BYB (4-Feb-22)
S21285/BYC (5-Feb-22)
S21286/BYD (11-Feb-22)
S21287/BYE (12-Feb-22)
S21290/BYH (16-Feb-22)
S21304/BYT (23-Feb-22)
S21306/BYV (24-Feb-22)
S21308/BYX (25-Feb-22)
S21310/BYZ (26-Feb-22)
S21379/CBM (14-Apr-22)
S21382/CBP (14-Apr-22)
S21385/CBS (15-Apr-22)
NDC:
70324-102-02

Quantity: 36,360 bags

Product: NOREPINEPHRINE in 0.9% Sodium Chloride Injection (8 mg per 250 mL)
Variants: 32 mcg per mL, Rx only
Lot Numbers:
S21162/BTT (13-Nov-21)
S21163/BTU (13-Nov-21)
S21167/BTY (19-Nov-21)
S21174/BUF (20-Nov-21)
S21175/BUG (21-Nov-21)
S21217/BVS (12-Dec-21)
S21218/BVT (12-Dec-21)
S21219/BVU (16-Dec-21)
S21241/BWL (24-Dec-21)
S21281/BXY (20-Jan-22)
S21282/BXZ (23-Jan-22)
S21283/BYA (22-Jan-22)
S21297/BYN (28-Jan-22)
S21340/CAA (27-Feb-22)
S21342/CAC (5-Mar-22)
S21352/CAL (6-Mar-22)
S21359/CAS (11-Mar-22)
S21362/CAV (12-Mar-22)
S21368/CBB (13-Mar-22)
S21369/CBC (19-Mar-22)
S21415/CCX (7-Apr-22)
S21419/CDB (7-Apr-22)
S21434/CDP (16-Apr-22)
NDC:
70324-676-01

Quantity: 74,508 bags

Product: NOREPINEPHRINE in 0.9% Sodium Chloride Injection (16 mg per 250 mL)
Variants: 64 mcg per mL
Lot Numbers:
S21082/BQV (13-Nov-21)
S21102/BRM (28-Nov-21)
S21135/BST (14-Dec-21)
S21166/BTX (7-Jan-22)
S21178/BUJ (28-Jan-22)
S21226/BVZ (5-Feb-22)
S21237/BWI (7-Feb-22)
S21242/BWM (13-Feb-22)
S21280/BXX (11-Mar-22)
S21302/BYS (21-Mar-22)
S21345/CAE (23-Apr-22)
S21424/CDG (28-May-22)
NDC:
70324-926-01

Quantity: 36,576 bags

Product: PHENYLephrine HCl in 0.9% Sodium Chloride Injection (40 mg per 250 mL)
Variants: 160 mcg per mL, Rx Only
Lot Numbers:
S21087/BQX (16-Dec-21)
S21151/BTJ (24-Jan-22)
S21186/BUQ (14-Feb-22)
S21189/BUS (16-Feb-22)
S21266/BXJ (3-Apr-22)
S21307/BYW (24-Apr-22)
S21313/BZC (27-Apr-22)
NDC:
70324-252-01

Quantity: 20,640 bags

Product: PHENYLephrine HCl in 0.9% Sodium Chloride Injection (50 mg per 250 mL)
Variants: 200 mg per mL, Rx Only
Lot Numbers:
S21088/BQY (19-Dec-21)
S21152/BTK (25-Jan-22)
S21161/BTS (31-Jan-22)
S21289/BYG (4-Apr-22)
S21309/BYY (25-Apr-22)
S21314/BZD (2-May-22)
S21378/CBL (12-Jun-22)
NDC:
70324-901-01

Quantity: 23,136 bags

Product: Sodium Bicarbonate in 5% Dextrose Injection
Variants: Rx Only
Lot Numbers:
S20459/BMP (17-Nov-21)
S20472/BMZ (18-Nov-21)
S20473/BNA (18-Nov-21)
NDC:
70324-326-03

Quantity: 2,886 bags

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89059
Status: Resolved
Manufacturer: SterRx, LLC
Sold By: Hospitals; Healthcare Facilities
Manufactured In: United States
Units Affected: 26 products (15660 bags; 880 units; 24300 bags; 9360 bags; 2779 bags; 18,948 bags; 127,260 bags; 3540 bags; 26,928 bags; 7548 bags; 5832 bags; 684 bags; 36360 bags; 40 bags; 1428 bags; 8946 bags; 10660 bags; 5000 bags; 880 bags; 1044 bags; 121,584 bags; 74,508 bags; 36,576 bags; 20640 bags; 23,136 bags; 2886 bags)
Distributed To: Nationwide

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.

Find an Attorney

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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 ยท 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.