Recalls / Class II
Class IID-0706-2023
Product
oxyTOCIN 20 units added to Lactated Ringer's 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6038-1.
- Affected lot / code info
- Lot # 37-889158, 37-889187, 37-889189, Exp 04/28/2023; 37-889494, 37-889507, 37-889522, 37-889525, 37-889527, 37-889608, Exp 04/29/2023; 37-889906, 37-889912, 37-889913, Exp 04/30/2023; 37-890110, 37-890121, Exp 05/03/2023; 37-891160, 37-891162, 37-891186, 37-891188, 37-891199, 37-891211, Exp 05/06/2023; 37-891564, 37-891565, 37-891567, 37-891569, 37-891570, Exp 05/07/2023; 37-892591, Exp 05/12/2023; 37-892893, 37-892897, 37-892900, 37-892902, 37-892903, 37-892904, 37-892909, 37-892910, Exp 05/13/2023; 37-894715, 37-894720, 37-894749, 37-894754, 37-894762, 37-894763, 37-894765, Exp 05/20/2023; 37-894991, 37-894992, 37-894993, Exp 05/21/2023; 37-896187, 37-896188, 37-896190, 37-896191, 37-896199, 05/26/2023; 37-896521, 37-896522, 37-896523, Exp 05/27/2023; 37-896883, 37-896884, Exp 05/28/2023; 37-900067, 37-900068, 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
- 14362 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-0706-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.