Drug & medication recalls Moderate risk

Metronidazole 500mg Tablet recalled over manufacturing violations

Recall date
July 7, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Safecor Health, LLC recalls Metronidazole 500mg Tablet, 50-count bottles, Rx only, Packaged By Safecor Health LLC Woburn, MA 01801, NDC 5011133402
Recall number
D-0905-2017
FDA classification
Class II
Brand / firm
Safecor Health, LLC
Sold / distributed
MA and NY

Why it was recalled

CGMP Deviations

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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