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Recall Observatory FDA recall evidence

Drug product

ceFAZolin sodium in Sterile Water for injection, Injectable Solution, 1g/10mL (0.1 g per mL), Syringe, Rx only, Wells Pharma, NDC 73702-131-10

D-0141-2024

November 22, 2023

Class II

Product summary

Firm
Wells Pharma of Houston LLC
Event
Event 93496
Status
Completed
Classification
Class II
Quantity
825 syringes
Official record key
drug-enforcement:D-0141-2024

Official wording

Reason: Lack of assurance of sterility.

Code information: Lot # 11092313110#01, Exp 01/12/24

Distribution pattern: Philadelphia, Pennsylvania.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility