Recalls / Class II
Class IID-0707-2023
Product
oxyTOCIN 30 units added to Lactated Ringer's 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6039-1.
- Affected lot / code info
- Lot # 37-889853, 37-889854, 37-889856, Exp 04/30/2023; 37-890087, 37-890088, 37-890095, 37-890098, 37-890100, 37-890107, 37-890109, Exp 05/03/2023; 37-890876, 37-890878, 37-890885, 37-890891, Exp 05/05/2023; 37-891572, Exp 05/07/2023; 37-892504, 37-892510, 37-892512, 37-892520, 37-892560, 37-892575, 37-892585, 37-892587, Exp 05/12/2023; 37-892988, 37-892989, Exp 05/13/2023; 37-894323, 37-894356, 37-894366, 37-894385, 37-894386, 37-894402, 37-894409, 37-894410, Exp 05/19/2023; 37-894778, Exp 05/20/2023; 37-894998, 37-894999, 37-895000, 37-895001, 37-895002, Exp 05/21/2023; 37-896186, 37-896189, 37-896192, 37-896194, 37-896200, 37-896202, 37-896227, 37-896231, 37-896240, 37-896241, Exp 05/26/2023; 37-896844, 37-896851, 37-896853, 37-896856, Exp 05/28/2023; 37-897827, 37-897836, 37-897837, 37-897853, 37-897854, 37-897928, Exp 06/02/2023; 37-900117, 37-900122, 37-900123, Exp 06/10/2023
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
- 21871 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-0707-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.