FDA Drug Recalls

Recalls / Class II

Class IID-0900-2017

Product

Acetaminophen 325mg tablets, 120-count bottles, Pk By Safecor Health Woburn, MA 01801, NDC 00904198280.

Affected lot / code info
Lot #: A18688, Exp. 09/30/2018

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
66 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-0900-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.