Recalls / Class II
Class IID-0723-2023
Product
vancomycin added to 0.9% sodium chloride, 2 g/500 mL* (4 mg/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6078-1.
- Affected lot / code info
- Lot # 37-884151, 37-884153, Exp 05/03/2023; 37-885670, 37-885869, 37-885900, Exp 05/09/2023; 37-886271, Exp 05/11/2023; 37-886857, 37-886862, 37-886865, 37-886923, Exp 05/15/2023; 37-889190, 37-889191, Exp 05/23/2023; 37-889596, Exp 05/24/2023; 37-890482, 37-890487, 37-890488, Exp 05/29/2023; 37-891230, Exp 05/31/2023; 37-892589, 37-892590, Exp 06/06/2023; 37-893779, 37-893780, 37-893781, Exp 06/12/2023; 37-894665, 37-894667, Exp 06/14/2023; 37-895608, 37-895625, Exp 06/19/2023; 37-896519, Exp 06/21/2023
Why it was recalled
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recalling firm
- Firm
- Central Admixture Pharmacy Services, Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 6580 Snowdrift Rd Ste 100, N/A, Allentown, Pennsylvania 18106-9331
Distribution
- Quantity
- 7632 bags
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2023-04-28
- FDA classified
- 2023-05-19
- Posted by FDA
- 2023-05-31
- Terminated
- 2025-06-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0723-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.