Wockhardt Usa Inc. recalls Amlodipine Besylate Tablets, 5 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-422-01) and B) 1000 Count Bottles
Recalled July 29, 2015 · FDA recall D-1255-2015 · Wockhardt Usa
Hazard
CGMP Deviations: Firm did not adequately investigate customer complaints. · FDA Class II
Units
A) 146,959 Bottles, B) 73,445 Bottles.
Sold at
U.S. Nationwide including Puerto Rico.
Description
CGMP Deviations: Firm did not adequately investigate customer complaints.
Product
Amlodipine Besylate Tablets, 5 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-422-01) and B) 1000 Count Bottles (NDC: 64679-422-02), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
Manufacturer(s)
Wockhardt Usa Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →