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Recall Observatory FDA recall evidence

Drug 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.

D-0708-2023

April 28, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services, Inc.
Event
Event 92253
Status
Terminated
Classification
Class II
Quantity
3865 bags
Official record key
drug-enforcement:D-0708-2023

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 # 37-883926, 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

Distribution pattern: Nationwide in the USA.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility