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Recall Observatory FDA recall evidence

Drug product

EPINEPHrine added to dextrose 5%, 2 mg/250 mL* (8 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6030-1.

D-0701-2023

April 28, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services, Inc.
Event
Event 92253
Status
Terminated
Classification
Class II
Quantity
3338 bags
Official record key
drug-enforcement:D-0701-2023

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 # 37-884448, Exp 05/04/2023; 37-887386, Exp 05/16/2023; 37-888271, Exp 05/21/2023; 37-891189, Exp 05/31/2023; 37-893456, Exp 06/11/2023; 37-894656, Exp 06/14/2023; 37-898333, Exp 06/28/2023; 37-898559, 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