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Recall Observatory FDA recall evidence

Drug product

oxyTOCIN 20 units added to 0.9% sodium chloride 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 72185-6043-1.

D-0709-2023

April 28, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services, Inc.
Event
Event 92253
Status
Terminated
Classification
Class II
Quantity
5544 bags
Official record key
drug-enforcement:D-0709-2023

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 # 37-883938, Exp 05/02/2023; 37-884910, 37-884915, Exp 05/07/2023; 37-886041, Exp 05/10/2023; 37-887515, 37-887520, Exp 05/16/2023; 37-888318, Exp 05/21/2023; 37-888847, Exp 05/22/2023; 37-890535, Exp 05/29/2023; 37-890957, Exp 05/30/2023; 37-891566, 37-891568, Exp 06/01/2023; 37-892156, Exp 06/05/2023; 37-893165, 37-893166, Exp 06/08/2023; 37-893994, 37-893995, Exp 06/12/2023; 37-895771, 37-895773, 37-895775, Exp 06/19/2023; 37-896614, Exp 06/21/2023; 37-900377, Exp 07/06/2023

Distribution pattern: Nationwide in the USA.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility