FDA-Drug2015-03-11Class II

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

Qualitest Pharmaceuticals
Hazard

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

Sold states
Nationwide
Affected count
2808 bottles
Manufactured in
120 Vintage Dr NE, N/A, Huntsville, AL, United States
Products
AMLODIPINE BESYLATE TABLETS USP, 10 mg*, 1000 count bottles (NDC 0603-2110-32), Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0397-2015

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