Amlodipine besylate tablets recalled over manufacturing violations

Recall date

June 1, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

American Health Packaging recalls Amlodipine besylate tablets, USP 10 mg, packaged in 10-count blisters (NDC 68084-506-11); 10 blister packs per carton (…

Recall number

D-1220-2015

FDA classification

Class II

Brand / firm

American Health Packaging

Sold / distributed

Nationwide

Why it was recalled

CGMP Deviations: Firm did not adequately investigate customer complaints.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Amlodipine besylate tablets, USP 10 mg, packaged in 10-count blisters (NDC 68084-506-11); 10 blister packs per carton (NDC 68084-506-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.