Recalls / Class II
Class IID-0717-2023
Product
vancomycin added to 0.9% sodium chloride, 1 g/250 mL* (4 mg/mL), 25 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6064-1.
- Affected lot / code info
- Lot # 37-885351, Exp 05/08/2023; 37-885979, Exp 05/10/2023; 37-887721, Exp 05/17/2023; 37-889212, Exp 05/23/2023; 37-889607, Exp 05/24/2023; 37-891247, Exp 05/31/2023; 37-892937, Exp 06/07/2023; 37-894025, Exp 06/12/2023; 37-894748, Exp 06/14/2023; 37-895282, Exp 06/18/2023; 37-896173, Exp 06/20/2023
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
- 4390 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-0717-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.