Recalls / Class II
Class IID-0708-2023
Product
oxyTOCIN 15 units added to 0.9% sodium chloride 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 72185-6042-1.
- Affected lot / code info
- Lot # 37-883926, Exp 05/02/2023; 37-886032, Exp 05/10/2023; 37-887681, Exp 05/17/2023; 37-888317, Exp 05/21/2023; 37-890906, Exp 05/30/2023; 37-892146, Exp 06/05/2023; 37-892507, Exp 06/06/2023; 37-894483, Exp 06/13/2023; 37-896595, Exp 06/21/2023; 37-898568, 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
- 3865 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-0708-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.