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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

CAPS Sterile Injectable Drugs and IV Bags Recalled for Potential Sterility Issues

Agency Publication Date: June 27, 2024
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Summary

Central Admixture Pharmacy Services Inc (CAPS) is recalling 66,961 units of various sterile injectable medications and intravenous bags due to a lack of assurance of sterility. The recall includes a wide range of medications such as Fentanyl, Ketamine, Phenylephrine, and Midazolam used in hospital and surgical environments. While no injuries or incidents have been reported, the sterility defect means the products may not be safe for patient administration. These products were distributed nationwide in the USA to hospitals, healthcare facilities, and pharmacies.

Risk

Medications intended for injection or intravenous use that are not guaranteed to be sterile pose a high risk of causing serious infections. Such infections can be life-threatening, particularly for surgery patients or those with compromised immune systems. To date, there have been no reported incidents or injuries associated with this recall.

What You Should Do

  1. This recall involves multiple medications including Fentanyl, Ketamine, Ephedrine, Lidocaine, Phenylephrine, Rocuronium, Midazolam, Succinylcholine, and Hydromorphone sold under the Central Admixture Pharmacy Services (CAPS) brand in various syringes and bags.
  2. Identify your product by checking the medication name, volume (3 mL, 5 mL, 10 mL, 30 mL, 50 mL, 100 mL, or 250 mL), and the NDC code printed on the label. See the Affected Products section below for the full list of affected lot numbers and expiration dates.
  3. Stop using the recalled product immediately. Contact the manufacturer or your distributor to arrange for the return of any remaining units.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information regarding this recall.

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: Fentanyl in 0.9% Sodium Chloride (3 mL syringe)by Central Admixture Pharmacy Services, Inc.
Variants: 10 mcg/mL, 10 mcg/1 mL
Lot Numbers:
17-275858 (Exp. 10/11/2023)
17-275967 (Exp. 10/15/2023)
17-275981 (Exp. 10/15/2023)
NDC:
71286-2071-7
Product: Ketamine in 0.9% Sodium Chloride (5 mL syringe)by CAPS, Inc.
Variants: 10 mg/mL, 50 mg/5 mL
Lot Numbers:
17-275224 (Exp. 10/2/2023)
17-275225 (Exp. 10/2/2023)
17-275233 (Exp. 10/2/2023)
17-275235 (Exp. 10/2/2023)
17-275253 (Exp. 10/2/2023)
17-275259 (Exp. 10/2/2023)
17-275263 (Exp. 10/2/2023)
17-275267 (Exp. 10/2/2023)
17-275340 (Exp. 10/3/2023)
17-275512 (Exp. 10/5/2023)
17-275633 (Exp. 10/8/2023)
17-275657 (Exp. 10/8/2023)
NDC:
71286-3022-1
Product: Ephedrine in 0.9% Sodium Chloride (5 mL syringe)by CAPS Inc.
Variants: 10 mg/mL, 50 mg/5 mL
Lot Numbers:
17-275252 (Exp. 10/2/2023)
17-275276 (Exp. 10/2/2023)
17-275525 (Exp. 10/5/2023)
NDC:
71286-6004-1
Product: Lidocaine 2% (5 mL syringe)by CAPS, Inc.
Variants: 20 mg/mL, 100 mg/5 mL
Lot Numbers:
17-275788 (Exp. 10/10/2023)
17-275872 (Exp. 10/11/2023)
17-275922 (Exp. 10/12/2023)
17-275972 (Exp. 10/15/2023)
17-275973 (Exp. 10/15/2023)
NDC:
71286-6006-1
Product: Phenylephrine in 0.9% Sodium Chloride (400 mcg/10 mL)by CAPS, Inc.
Variants: 40 mcg/mL, 10 mL syringe
Lot Numbers:
17-275231 (Exp. 10/2/2023)
17-275232 (Exp. 10/2/2023)
17-275563 (Exp. 10/8/2023)
17-275567 (Exp. 10/8/2023)
17-275573 (Exp. 10/8/2023)
17-275580 (Exp. 10/8/2023)
17-275767 (Exp. 10/10/2023)
17-275784 (Exp. 10/10/2023)
NDC:
71286-6007-1
Product: Phenylephrine in 0.9% Sodium Chloride (800 mcg/10 mL)by CAPS, Inc.
Variants: 80 mcg/mL, 10 mL syringe
Lot Numbers:
17-275323 (Exp. 10/3/2023)
17-275345 (Exp. 10/3/2023)
17-275642 (Exp. 10/8/2023)
17-275643 (Exp. 10/8/2023)
17-275671 (Exp. 10/8/2023)
17-275675 (Exp. 10/9/2023)
17-275677 (Exp. 10/9/2023)
17-276188 (Exp. 10/18/2023)
NDC:
71286-6008-1
Product: Phenylephrine in 0.9% Sodium Chloride (1,000 mcg/10 mL)by Central Admixture Pharmacy Services, Inc.
Variants: 100 mcg/mL, 10 mL syringe
Lot Numbers:
17-275152 (Exp. 10/1/2023)
17-275154 (Exp. 10/1/2023)
17-275155 (Exp. 10/1/2023)
17-275156 (Exp. 10/1/2023)
17-275163 (Exp. 10/1/2023)
17-275234 (Exp. 10/2/2023)
17-275236 (Exp. 10/2/2023)
17-275251 (Exp. 10/2/2023)
17-275268 (Exp. 10/2/2023)
17-275270 (Exp. 10/2/2023)
17-275277 (Exp. 10/2/2023)
17-275283 (Exp. 10/3/2023)
17-275294 (Exp. 10/3/2023)
17-275313 (Exp. 10/3/2023)
17-275469 (Exp. 10/4/2023)
17-275471 (Exp. 10/4/2023)
17-275473 (Exp. 10/4/2023)
17-275480 (Exp. 10/4/2023)
17-275481 (Exp. 10/4/2023)
17-275482 (Exp. 10/4/2023)
17-275483 (Exp. 10/4/2023)
17-275484 (Exp. 10/4/2023)
17-275485 (Exp. 10/4/2023)
17-2754990 (Exp. 10/4/2023)
17-2754991 (Exp. 10/4/2023)
17-2754993 (Exp. 10/4/2023)
17-275558 (Exp. 10/8/2023)
17-275654 (Exp. 10/8/2023)
17-275667 (Exp. 10/8/2023)
17-275722 (Exp. 10/9/2023)
17-275737 (Exp. 10/9/2023)
17-275768 (Exp. 10/10/2023)
17-275804 (Exp. 10/10/2023)
17-275805 (Exp. 10/10/2023)
17-275847 (Exp. 10/11/2023)
17-275849 (Exp. 10/11/2023)
17-275857 (Exp. 10/11/2023)
17-275882 (Exp. 10/11/2023)
17-275923 (Exp. 10/12/2023)
17-275983 (Exp. 10/15/2023)
17-275984 (Exp. 10/15/2023)
17-276123 (Exp. 10/17/2023)
17-276125 (Exp. 10/18/2023)
17-276126 (Exp. 10/18/2023)
NDC:
71286-6009-1
Product: Rocuronium (5 mL syringe)by Central Admixture Pharmacy Services, Inc.
Variants: 10 mg/mL, 50 mg/5 mL
Lot Numbers:
17-275634 (Exp. 10/8/2023)
17-275860 (Exp. 10/11/2023)
17-276174 (Exp. 10/18/2023)
NDC:
71286-6010-1
Product: Fentanyl in 0.9% Sodium Chloride (3 mL syringe, NDC 71286-2071-1)by Central Admixture Pharmacy Services, Inc.
Variants: 10 mcg/mL, 10 mcg/1 mL
Lot Numbers:
17-275621 (Exp. 10/8/2023)
17-275693 (Exp. 10/9/2023)
17-275725 (Exp. 10/9/2023)
NDC:
71286-2071-1
Product: Fentanyl in 0.9% Sodium Chloride (10 mL syringe)by Central Admixture Pharmacy Services, Inc.
Variants: 10 mcg/mL, 100 mcg/10 mL
Lot Numbers:
17-275476 (Exp. 10/4/2023)
17-275875 (Exp. 10/11/2023)
NDC:
71286-2071-2
Product: Fentanyl in 0.9% Sodium Chloride (50 mL syringe)by Central Admixture Pharmacy Services, Inc.
Variants: 10 mcg/mL, 500 mcg/50 mL
Lot Numbers:
17-275341 (Exp. 10/3/2023)
17-275853 (Exp. 10/11/2023)
NDC:
71286-2071-3
Product: Fentanyl in 0.9% Sodium Chloride (100 mL bag)by CAPS
Variants: 10 mcg/mL, 1,000 mcg/100 mL
Lot Numbers:
17-275314 (Exp. 10/3/2023)
17-275319 (Exp. 10/3/2023)
17-275320 (Exp. 10/3/2023)
17-275324 (Exp. 10/3/2023)
17-275327 (Exp. 10/3/2023)
17-275328 (Exp. 10/3/2023)
17-275349 (Exp. 10/3/2023)
17-275510 (Exp. 10/5/2023)
17-275531 (Exp. 10/5/2023)
17-275536 (Exp. 10/5/2023)
17-275541 (Exp. 10/5/2023)
17-275548 (Exp. 10/5/2023)
17-275656 (Exp. 10/8/2023)
17-275714 (Exp. 10/9/2023)
17-275766 (Exp. 10/10/2023)
17-275786 (Exp. 10/10/2023)
17-275787 (Exp. 10/10/2023)
17-275802 (Exp. 10/10/2023)
17-275918 (Exp. 10/12/2023)
17-275926 (Exp. 10/12/2023)
17-275951 (Exp. 10/13/2023)
17-275966 (Exp. 10/15/2023)
17-275975 (Exp. 10/15/2023)
17-275977 (Exp. 10/15/2023)
17-276103 (Exp. 10/17/2023)
NDC:
71286-2071-4
Product: Fentanyl in 0.9% Sodium Chloride (250 mL bag, NDC 71286-2071-5)by Central Admixture Pharmacy Services, Inc.
Variants: 10 mcg/mL, 2,500 mcg/250 mL
Lot Numbers:
17-275164 (Exp. 10/1/2023)
17-275623 (Exp. 10/8/2023)
17-275631 (Exp. 10/8/2023)
17-275640 (Exp. 10/8/2023)
17-275649 (Exp. 10/8/2023)
17-275650 (Exp. 10/8/2023)
17-275655 (Exp. 10/8/2023)
17-275660 (Exp. 10/8/2023)
17-275712 (Exp. 10/9/2023)
17-275713 (Exp. 10/9/2023)
17-275721 (Exp. 10/9/2023)
17-275723 (Exp. 10/9/2023)
17-275727 (Exp. 10/9/2023)
17-276232 (Exp. 10/19/2023)
NDC:
71286-2071-5
Product: Fentanyl in 0.9% Sodium Chloride (250 mL bag, NDC 71286-2074-1)by Central Admixture Pharmacy Services, Inc.
Variants: 20 mcg/mL, 5,000 mcg/250 mL
Lot Numbers:
17-275517 (Exp. 10/5/2023)
17-275862 (Exp. 10/11/2023)
17-275980 (Exp. 10/15/2023)
17-276036 (Exp. 10/16/2023)
NDC:
71286-2074-1
Product: Fentanyl and Bupivacaine 0.125% PF (50 mL syringe)by Central Admixture Pharmacy Services, Inc.
Variants: Fentanyl 1.5 mcg/mL, 75 mcg/50 mL
Lot Numbers:
17-275165 (Exp. 10/1/2023)
17-275166 (Exp. 10/1/2023)
17-275217 (Exp. 10/2/2023)
17-275715 (Exp. 10/9/2023)
17-276035 (Exp. 10/16/2023)
17-276112 (Exp. 10/17/2023)
NDC:
71286-2080-2
Product: Fentanyl and Bupivacaine 0.0625% PF (250 mL bag)by Central Admixture Pharmacy Services, Inc.
Variants: Fentanyl 2 mcg/mL, 500 mcg/250 mL
Lot Numbers:
17-275929 (Exp. 10/12/2023)
NDC:
71286-2081-1
Product: Fentanyl and Bupivacaine 0.125% PF (250 mL bag)by Central Admixture Pharmacy Services, Inc.
Variants: Fentanyl 2 mcg/mL, 500 mcg/250 mL
Lot Numbers:
17-275974 (Exp. 10/15/2023)
17-275979 (Exp. 10/15/2023)
17-276110 (Exp. 10/17/2023)
17-276234 (Exp. 10/19/2023)
NDC:
71286-2082-2
Product: Midazolam in Dextrose 5% (50 mL syringe)by Central Admixture Pharmacy Services, Inc.
Variants: 1 mg/mL, 50 mg/50 mL
Lot Numbers:
17-275475 (Exp. 10/4/2023)
17-276117 (Exp. 10/17/2023)
NDC:
71286-4036-1
Product: Fentanyl (3 mL syringe, NDC 71286-2003-1)by Repackaged by CAPS Inc.
Variants: 50 mcg/mL, 100 mcg/2 mL
Lot Numbers:
17-275284 (Exp. 10/3/2023)
NDC:
71286-2003-1
Product: Fentanyl (5 mL syringe, NDC 71286-2003-2)by Repackaged by CAPS Inc.
Variants: 50 mcg/mL, 250 mcg/5 mL
Lot Numbers:
17-275479 (Exp. 10/4/2023)
17-275852 (Exp. 10/11/2023)
NDC:
71286-2003-2
Product: Fentanyl (50 mL syringe, NDC 71286-2003-3)by CAPS
Variants: 50 mcg/mL, 2,500 mcg/50 mL
Lot Numbers:
17-275464 (Exp. 10/4/2023)
17-275850 (Exp. 10/11/2023)
NDC:
71286-2003-3
Product: Fentanyl (100 mL bag, NDC 71286-2003-4)by Central Admixture Pharmacy Services, Inc.
Variants: 50 mcg/mL, 2,500 mcg/50 mL
Lot Numbers:
17-275704 (Exp. 10/9/2023)
NDC:
71286-2003-4
Product: Fentanyl (100 mL bag, NDC 71286-2003-5)by Central Admixture Pharmacy Services, Inc.
Variants: 50 mcg/mL, 5,000 mcg/100 mL
Lot Numbers:
17-275322 (Exp. 10/3/2023)
NDC:
71286-2003-5
Product: Fentanyl in Dextrose 5% (30 mL syringe)by Central Admixture Pharmacy Services, Inc.
Variants: 10 mcg/mL, 300 mcg/30 mL
Lot Numbers:
17-275321 (Exp. 10/3/2023)
17-275779 (Exp. 10/10/2023)
17-275790 (Exp. 10/10/2023)
NDC:
71286-2001-2
Product: Fentanyl (30 mL syringe, NDC 71286-2003-7)by Central Admixture Pharmacy Services, Inc.
Variants: 50 mcg/mL, 1,250 mcg/25 mL
Lot Numbers:
17-275223 (Exp. 10/2/2023)
17-275275 (Exp. 10/2/2023)
17-275928 (Exp. 10/12/2023)
17-276088 (Exp. 10/17/2023)
17-276118 (Exp. 10/17/2023)
NDC:
71286-2003-7
Product: Succinylcholine (10 mL syringe)by CAPS, Inc.
Variants: 20 mg/mL, 200 mg/10 mL
Lot Numbers:
17-275343 (Exp. 10/3/2023)
17-275472 (Exp. 10/4/2023)
17-275489 (Exp. 10/4/2023)
17-275876 (Exp. 10/11/2023)
17-275976 (Exp. 10/15/2023)
17-275985 (Exp. 10/15/2023)
17-276204 (Exp. 10/18/2023)
NDC:
71286-6011-2
Product: Hydromorphone in 0.9% Sodium Chloride (30 mL syringe, NDC 71286-2010-1)by CAPS
Variants: 0.2 mg/mL, 6 mg/30 mL
Lot Numbers:
17-275680 (Exp. 10/8/2023)
17-275945 (Exp. 10/13/2023)
17-276094 (Exp. 10/17/2023)
NDC:
71286-2010-1
Product: Hydromorphone in 0.9% Sodium Chloride (50 mL syringe)by Central Admixture Pharmacy Services, Inc.
Variants: 0.2 mg/mL, 10 mg/50 mL
Lot Numbers:
17-275728 (Exp. 10/9/2023)
17-275791 (Exp. 10/10/2023)
17-275803 (Exp. 10/10/2023)
17-276244 (Exp. 10/20/2023)
NDC:
71286-2010-2
Product: Hydromorphone in 0.9% Sodium Chloride (30 mL syringe, NDC 71286-2011-1)by Central Admixture Pharmacy Services, Inc.
Variants: 0.5 mg/mL, 15 mg/30 mL
Lot Numbers:
17-275315 (Exp. 10/3/2023)
17-275466 (Exp. 10/4/2023)
17-275477 (Exp. 10/4/2023)
17-276102 (Exp. 10/17/2023)
17-276221 (Exp. 10/19/2023)
NDC:
71286-2011-1
Product: Hydromorphone in Dextrose 5% (30 mL syringe)by Central Admixture Pharmacy Services, Inc.
Variants: 0.1 mg/mL, 3 mg/30 mL
Lot Numbers:
17-275266 (Exp. 10/2/2023)
17-275666 (Exp. 10/8/2023)
NDC:
71286-2013-2
Product: Hydromorphone in 0.9% Sodium Chloride (30 mg/30 mL)by Central Admixture Pharmacy Services, Inc.
Variants: 1 mg/mL, 30 mL syringe
Lot Numbers:
17-275339 (Exp. 10/3/2023)
17-275478 (Exp. 10/4/2023)
17-275488 (Exp. 10/4/2023)
17-275620 (Exp. 10/8/2023)
17-275777 (Exp. 10/10/2023)
17-275793 (Exp. 10/10/2023)
17-275863 (Exp. 10/11/2023)
17-275958 (Exp. 10/11/2023)
17-276027 (Exp. 10/16/2023)
17-275730 (Exp. 10/9/2023)
NDC:
71286-2012-1
Product: Hydromorphone in Dextrose 5% (5 mL syringe)by Central Admixture Pharmacy Services, Inc.
Variants: 0.1 mg/mL, 0.5 mg/5 mL
Lot Numbers:
17-275730 (Exp. 10/09/2023)
NDC:
71286-2012-1

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93103
Status: Resolved
Manufacturer: Central Admixture Pharmacy Services Inc
Sold By: Hospitals; Healthcare Facilities; Pharmacies
Manufactured In: United States
Units Affected: 32 products (1,762 Syringes; 4,775 5 mL Syringes; 1,590 5 mL Syringes.; 1,992 5 mL syringes; 3,384 10 mL syringes; 3,081 syringes; 19,510 10 mL syringes.; 1,389 5 mL syringes; 1,767 3 mL syringes; 598 10 mL syringes; 688 50 mL syringes; 5,378 100 mL bags; 1,792 bags; 403 bags; 895 50 mL syringes; 60 250 mL bags; 190 250 mL bags; 419 50 mL syringes; 50, 3 mL syringes; 174, 5 mL syringes.; 476, 50 mL Syringes; 240 100 mL bags; 71 100 mL bags; 962 30 mL syringes.; 1,459 30 mL syringes; 3,590 10 mL syringes; 1,190 30 mL syringes; 1,190 50 mL syringes; 4,550 30 mL syringes; 274 30 mL syringes; 2,664 30 mL syringes; 398 5 mL syringes)
Distributed To: Nationwide

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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.