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Recall Observatory FDA recall evidence

Drug product

oxyTOCIN 40 units added to 0.9% sodium chloride 1,000 bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8069-1.

D-0740-2023

April 28, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services, Inc.
Event
Event 92253
Status
Terminated
Classification
Class II
Quantity
2186 bags
Official record key
drug-enforcement:D-0740-2023

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 # 37-886265, Exp 05/11/2023; 37-886266, Exp 05/11/2023; 37-889903, Exp 05/25/2023; 37-890551, Exp 05/29/2023; 37-892521, 37-892620, Exp 06/06/2023; 37-896246, 37-896247, Exp 06/20/2023; 37-898553, 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