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Recall Observatory FDA recall evidence

Drug product

vancomycin added to 0.9% sodium chloride, 750 mg/250 mL* (3 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6071-1.

D-0718-2023

April 28, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services, Inc.
Event
Event 92253
Status
Terminated
Classification
Class II
Quantity
3075 bags
Official record key
drug-enforcement:D-0718-2023

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 # 37-884161, Exp 05/03/2023; 37-885995, 37-885997, Exp 05/10/2023; 37-887729, Exp 05/17/2023; 37-889595, Exp 05/24/2023; 37-891272, Exp 05/31/2023; 37-892162, Exp 06/05/2023; 37-894716, Exp 06/14/2023

Distribution pattern: Nationwide in the USA.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility