FDA Drug Recalls

Recalls / Class II

Class IID-1039-2016

Product

tabcin ACTIVE M.R. Capsules, 12-count box , UPC 7501008485057

Affected lot / code info
Lot # 224TS; Exp. 02/17

Why it was recalled

CGMP Deviations

Recalling firm

Firm
Profarma Distributors LLC
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
4751 Poth Rd, N/A, Columbus, Ohio 43213-1331

Distribution

Quantity
42 boxes (504 capsules)
Distribution pattern
Nationwide

Timeline

Recall initiated
2016-05-11
FDA classified
2016-06-17
Posted by FDA
2016-06-29
Terminated
2017-01-24
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1039-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls