Wockhardt Usa Inc. recalls Azithromycin Tablets, USP, 500 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0964-01) and B) 3 x 3 Tablet Card
Recalled July 29, 2015 · FDA recall D-1263-2015 · Wockhardt Usa
Hazard
CGMP Deviations: Firm did not adequately investigate customer complaints. · FDA Class II
Units
A) 112,120 Bottles and B) 178,580 Cartons.
Sold at
U.S. Nationwide including Puerto Rico.
Description
CGMP Deviations: Firm did not adequately investigate customer complaints.
Product
Azithromycin Tablets, USP, 500 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0964-01) and B) 3 x 3 Tablet Card Cartons (NDC: 64679-964-05), 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 →