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Recall Observatory FDA recall evidence

Drug product

Metronidazole 500mg Tablet, 50-count bottles, Rx only, Packaged By Safecor Health LLC Woburn, MA 01801, NDC 5011133402

D-0905-2017

July 07, 2016

Class II

Product summary

Firm
Safecor Health, LLC
Event
Event 74822
Status
Terminated
Classification
Class II
Quantity
1,933 bottles
Official record key
drug-enforcement:D-0905-2017

Official wording

Reason: CGMP Deviations

Code information: Lot # A25593, Exp. 02/22/2017

Distribution pattern: MA and NY

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations