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Recall Observatory FDA recall evidence

Drug product

MSA 7.84% MSG 8.56% (0.92M) Comp. Sol. 1000 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8029-1, code 7128580291.

D-0750-2023

April 28, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services, Inc.
Event
Event 92253
Status
Terminated
Classification
Class II
Quantity
653 bags
Official record key
drug-enforcement:D-0750-2023

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 # 37-882955, Exp 04/29/2023; 37-884753, 37-884755, Exp 05/06/2023; 37-887536, 37-887537, Exp 05/17/2023; 37-888532, Exp 05/23/2023; 37-892474, Exp 06/07/2023; 37-896761, Exp 06/23/2023; 37-897261, Exp 06/27/2023

Distribution pattern: Nationwide in the USA.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility