Recalls / Class II
Class IID-0749-2023
Product
vasopressin 50 units added to 0.9% sodium chloride 50 mL*, 1 unit/mL*, 50 mL in 100 mL Partial Additive Bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-9002-1.
- Affected lot / code info
- Lot # 37-883209, 37-883211, 37-883212, 37-883214, 37-883215, Exp 04/30/2023; 37-883776, Exp 05/02/2023; 37-884451, Exp 05/04/2023; 37-884805, 37-884806, 37-884808, 37-884810, 37-884811, Exp 05/07/2023; 37-886498, 37-886506, 37-886507, 37-886509, 37-886511, 37-886512, Exp 05/14/2023; 37-887319, 37-887321, Exp 05/16/2023; 37-889572, 37-889574, Exp 05/24/2023; 37-890881, 37-890883, 37-890884, 37-890887, Exp 05/30/2023; 37-892003, 37-892004, 37-892006, Exp 06/05/2023; 37-893157, Exp 06/08/2023; 37-893460, 37-893461, 37-893463, Exp 06/11/2023; 37-894619, 37-894648, 37-894650, Exp 06/14/2023; 37-895213, 37-895216, 37-895219, 37-895223, 37-895225, Exp 06/18/2023; 37-896813, Exp 06/22/2023; 37-897069, 37-897074, Exp 06/25/2023
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
- 4259 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-0749-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.