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Recall Observatory FDA recall evidence

Drug product

oxyTOCIN 30 units added to dextrose 5%/Lactated Ringer's 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6032-1.

D-0703-2023

April 28, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services, Inc.
Event
Event 92253
Status
Terminated
Classification
Class II
Quantity
2624 bags
Official record key
drug-enforcement:D-0703-2023

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 # 37-883948, Exp 05/02/2023; 37-886037, 37-886040, Exp 05/10/2023; 37-889593, Exp 05/24/2023; 37-891270, Exp 05/31/2023; 37-893223, Exp 06/08/2023; 37-896230, Exp 06/20/2023; 37-898520, 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