PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: March 11, 2015 Initiated: February 13, 2015 #D-0397-2015

Product Description

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

Reason for Recall

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

Details

Recalling Firm
Qualitest Pharmaceuticals
Units Affected
2808 bottles
Distribution
Nationwide
Location
Huntsville, AL

Frequently Asked Questions

What product was recalled?
AMLODIPINE BESYLATE TABLETS USP, 10 mg*, 1000 count bottles (NDC 0603-2110-32), Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811. Recalled by Qualitest Pharmaceuticals. Units affected: 2808 bottles.
Why was this product recalled?
Failed tablet specifications: One lot was found to contain oversized tablets.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 11, 2015. Severity: Moderate. Recall number: D-0397-2015.