FDA Drug Recalls

Recalls / Class II

Class IID-010-2013

Product

Perphenazine Tablets, USP, 8 mg, 100-count tablets per bottle, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-5092-21.

Affected lot / code info
Lot C1130511A, Exp 5/13

Why it was recalled

Tablet Separation: Possibility of cracked or split coating on the tablets.

Recalling firm

Firm
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
120 Vintage Dr NE, N/A, Huntsville, Alabama 35811-8216

Distribution

Quantity
2,755 bottles
Distribution pattern
Nationwide and Puerto Rico

Timeline

Recall initiated
2012-10-11
FDA classified
2012-10-22
Posted by FDA
2012-10-31
Terminated
2013-12-09
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-010-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.