FDA Drug Recalls

Recalls / Class II

Class IID-0905-2017

Product

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

Affected lot / code info
Lot # A25593, Exp. 02/22/2017

Why it was recalled

CGMP Deviations

Recalling firm

Firm
Safecor Health, LLC
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
317 New Boston St, N/A, Woburn, Massachusetts 01801-6231

Distribution

Quantity
1,933 bottles
Distribution pattern
MA and NY

Timeline

Recall initiated
2016-07-07
FDA classified
2017-06-12
Posted by FDA
2017-06-21
Terminated
2017-07-12
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0905-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.