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Recall Observatory FDA recall evidence

Drug product

EPINEPHrine added to dextrose 5%, 8 mg/250 mL* (32 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7019-1.

D-0730-2023

April 28, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services, Inc.
Event
Event 92253
Status
Terminated
Classification
Class II
Quantity
2542 bags
Official record key
drug-enforcement:D-0730-2023

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 # 37-884156, Exp 05/03/2023; 37-885207, Exp 05/08/2023; 37-885929, Exp 05/10/2023; 37-886496, Exp 05/14/2023; 37-886817, Exp 05/15/2023; 37-887420, Exp 05/16/2023; 37-893786, Exp 06/12/2023; 37-894303, Exp 06/13/2023; 37-897893, Exp 06/27/2023; 37-900073, Exp 07/05/2023

Distribution pattern: Nationwide in the USA.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility