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Recall Observatory FDA recall evidence

Drug product

vancomycin added to 0.9% sodium chloride, 1 g/250 mL* (4 mg/mL), 25 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6064-1.

D-0717-2023

April 28, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services, Inc.
Event
Event 92253
Status
Terminated
Classification
Class II
Quantity
4390 bags
Official record key
drug-enforcement:D-0717-2023

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 # 37-885351, Exp 05/08/2023; 37-885979, Exp 05/10/2023; 37-887721, Exp 05/17/2023; 37-889212, Exp 05/23/2023; 37-889607, Exp 05/24/2023; 37-891247, Exp 05/31/2023; 37-892937, Exp 06/07/2023; 37-894025, Exp 06/12/2023; 37-894748, Exp 06/14/2023; 37-895282, Exp 06/18/2023; 37-896173, Exp 06/20/2023

Distribution pattern: Nationwide in the USA.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility