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Recall Observatory FDA recall evidence

Drug 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.

D-0702-2023

April 28, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services, Inc.
Event
Event 92253
Status
Terminated
Classification
Class II
Quantity
7595 bags
Official record key
drug-enforcement:D-0702-2023

Official wording

Reason: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Code information: 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

Distribution pattern: Nationwide in the USA.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility