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Recall Observatory FDA recall evidence

Drug product

EPINEPHrine added to dextrose 5%, 4 mg/250 mL* (16 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7018-1.

D-0729-2023

April 28, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services, Inc.
Event
Event 92253
Status
Terminated
Classification
Class II
Quantity
5627 bags
Official record key
drug-enforcement:D-0729-2023

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 # 37-883218, Exp 04/30/2023; 37-885235, Exp 05/08/2023; 37-885923, Exp 05/10/2023; 37-889050, Exp 05/23/2023; 37-890053, 37-890054, Exp 05/28/2023; 37-891439, 37-891441, Exp 06/01/2023; 37-892500, Exp 06/06/2023; 37-894308, Exp 06/13/2023; 37-896125, Exp 06/20/2023; 37-896926, Exp 06/22/2023; 37-900396, 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