Recalls / Class II
Class IID-0736-2023
Product
vancomycin added to 0.9% sodium chloride, 1.75 g/500 mL* (3.5 mg/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7060-1.
- Affected lot / code info
- Lot # 37-884152, 37-884158, Exp 05/03/2023; 37-885300, 37-885302, 37-885307, Exp 05/08/2023; 37-887418, 37-887431, 37-887432, Exp 05/16/2023; 37-888850, 37-888852, 37-888853, Exp 05/22/2023; 37-889188, Exp 05/23/2023; 37-890892, 37-890894, 37-890897, Exp 05/30/2023; 37-891232, Exp 05/31/2023; 37-892014, 37-892017, Exp 06/05/2023; 37-894411, 37-894412, 37-894414, Exp 06/13/2023; 37-894659, Exp 06/14/2023; 37-896078, 37-896089, 37-896097, Exp 06/20/2023; 37-897369, Exp 06/26/2023
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
- 8252 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-0736-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.