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Recall Observatory FDA recall evidence

Drug product

HyperLyte CR Injection, 250 mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8094-2, code 7128580942.

D-0755-2023

April 28, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services, Inc.
Event
Event 92253
Status
Terminated
Classification
Class II
Quantity
1673 bags
Official record key
drug-enforcement:D-0755-2023

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 # 37-885553, 37-885554, Exp 05/09/2023; 37-887923, 37-887924, Exp 05/18/2023; 37-890778, 37-890779, Exp 05/30/2023; 37-892847, Exp 06/07/2023; 37-895049, Exp 06/15/2023; 37-898480, 37-898481, 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