Recalls / Class II
Class IID-0725-2023
Product
vancomycin added to 0.9% sodium chloride, 1.5 g/500 mL* (3 mg/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6176-1.
- Affected lot / code info
- Lot # 37-883372, 37-883387, Exp 05/01/2023; 37-883790, Exp 05/02/2023; 37-884160, Exp 05/03/2023; 37-885320, 37-885321, 37-885324, Exp 05/08/2023; 37-885921, 37-885928, 37-885930, Exp 05/10/2023; 37-886270, Exp 05/11/2023; 37-887511, Exp 05/16/2023; 37-887666, 37-887670, Exp 05/17/2023; 37-888115, Exp 05/18/2023; 37-888841, Exp 05/22/2023; 37-889457, 37-889462, Exp 05/24/2023; 37-892638, 37-892641, 37-892648, Exp 06/06/2023; 37-892907, Exp 06/07/2023; 37-894437, 37-894443, 37-894450, Exp 06/13/2023; 37-895707, 37-895718, 37-895723, Exp 06/19/2023; 37-896532, 37-896535, Exp 06/21/2023; 37-898527, Exp 06/29/2023
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
- 11338 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-0725-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.