Recalls / Class II
Class IID-0702-2023
Product
oxyTOCIN 20 units added to dextrose 5%/Lactated Ringer's 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6031-1.
- Affected lot / code info
- Lot # 37-883206, 37-883207, 37-883210, 37-883213, 37-883216, 37-883217, 37-883217, Exp 04/30/2023; 37-884447, 37-884450, Exp 05/04/2023; 37-886269, Exp 05/11/2023; 37-887516, Exp 05/16/2023; 37-888306, 37-888308, 37-888310, 37-888311, Exp 05/21/2023; 37-890097, 37-890099, 37-890101, 37-890108, Exp 05/28/2023; 37-892636, 37-892637, 37-892639, 37-892640, Exp 06/06/2023; 37-894451, 37-894452, 37-894476, 37-894482, Exp 06/13/2023; 37-895311, 37-895312, 37-895313, Exp 06/18/2023; 37-895804, Exp 06/19/2023; 37-896607, 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
- 7595 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-0702-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.