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Recall Observatory FDA recall evidence

Drug product

EPINEPHrine added to 0.9% sodium chloride, 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 71285-8093-1.

D-0742-2023

April 28, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services, Inc.
Event
Event 92253
Status
Terminated
Classification
Class II
Quantity
8171 bags
Official record key
drug-enforcement:D-0742-2023

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 # 37-882988, Exp 04/28/2023; 37-883194, 37-883208, Exp 04/30/2023; 37-884746, Exp 05/05/2023; 37-885215, Exp 05/08/2023; 37-885927, Exp 05/10/2023; 37-887044, 37-887051, Exp 05/15/2023; 37-887667, Exp 05/17/2023; 37-888297, 37-888298, Exp 05/21/2023; 37-890886, Exp 05/30/2023; 37-891438, Exp 06/01/2023; 37-892497, Exp 06/06/2023; 37-893159, Exp 06/08/2023; 37-893843, Exp 06/12/2023; 37-894649, Exp 06/14/2023; 37-896928, Exp 06/22/2023; 37-899304, Exp 07/03/2023

Distribution pattern: Nationwide in the USA.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility