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Recall Observatory FDA recall evidence

Drug product

VANCOMYCIN 1.25 g added to 0.9% Sodium Chloride 250 mL Injection, 250 mL bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0923-59, Bar Code 70004092359

D-0425-2024

November 09, 2023

Class II

Product summary

Firm
SCA Pharmaceuticals, LLC
Event
Event 93456
Status
Terminated
Classification
Class II
Quantity
368 bags
Official record key
drug-enforcement:D-0425-2024

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 1223049049 Exp 12/28/23

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility