Recalls / Class II

Class IID-0397-2015

Product

AMLODIPINE BESYLATE TABLETS USP, 10 mg*, 1000 count bottles (NDC 0603-2110-32), Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811

Affected lot / code info

Lot T018H14A, Exp 08/16

Why it was recalled

Failed tablet specifications: One lot was found to contain oversized tablets.

Recalling firm

Firm

Qualitest Pharmaceuticals

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

120 Vintage Dr NE, N/A, Huntsville, Alabama 35811-8216

Distribution

Quantity

2808 bottles

Distribution pattern

Nationwide

Timeline

Recall initiated

2015-02-13

FDA classified

2015-03-03

Posted by FDA

2015-03-11

Terminated

2016-01-27

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0397-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.