Recalls / Class II
Class IID-0720-2023
Product
vancomycin added to 0.9% sodium chloride, 1.25 g/250 mL* (5 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6074-1.
- Affected lot / code info
- Lot # 37-883407, 37-883436, Exp 05/01/2023; 37-883796, 37-883797, 37-883800, 37-883802, 37-883806, Exp 05/02/2023; 37-884162, 37-884163, Exp 05/03/2023; 37-885332, 37-885336, 37-885337, Exp 05/08/2023; 37-885749, 37-885753, 37-885755, Exp 05/09/2023; 37-886008, 37-886027, 37-886031, 37-886035, Exp 05/10/2023; 37-886273, 37-886274, 37-886275, Exp 05/11/2023; 37-887448, 37-887457, Exp 05/16/2023; 37-887765, 37-887772, 37-887775, Exp 05/17/2023; 37-888062, 37-888072, Exp 05/18/2023; 37-888811, 37-888817, Exp 05/22/2023; 37-889193, 37-889208, 37-889210, Exp 05/23/2023; 37-889450, 37-889451, 37-889454, Exp 05/24/2023; 37-890940, 37-890941, 37-890952, Exp 05/30/2023; 37-891137, 37-891138, 37-891139, Exp 05/31/2023; 37-892633, 37-892634, 37-892635, Exp 06/06/2023; 37-892934, 37-892961, 37-892964, 37-892965, Exp 06/07/2023; 37-893524, Exp 06/11/2023; 37-893993, 37-893996, Exp 06/12/2023; 37-894465, 37-894466, 37-894467, 37-894468, Exp 06/13/2023; 37-894706, 37-894714, Exp 06/14/2023; 37-895680, 37-895682, Exp 06/19/2023; 37-896123, Exp 06/20/2023; 37-896564, 37-896579, 37-896586, 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
- 27780 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-0720-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.