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Recall Observatory FDA recall evidence

Drug product

Metronidazole Injection, USP, 500 mg/100 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-001-24

D-0616-2017

March 10, 2017

Class II

Product summary

Firm
Claris Lifesciences Inc
Event
Event 76733
Status
Terminated
Classification
Class II
Quantity
72072 units
Official record key
drug-enforcement:D-0616-2017

Official wording

Reason: Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.

Code information: Lot #: A060205; A060209, Exp.Jan 2018

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility