Wockhardt Usa Inc. recalls Azithromycin Tablets, USP, 250 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0961-01), B) 3,500 Count Pouches
Recalled July 29, 2015 · FDA recall D-1248-2015 · Wockhardt Usa
Hazard
CGMP Deviations: Firm did not adequately investigate customer complaints. · FDA Class II
Units
A) 280,520 Bottles, B) 571 Pouches, and C) 1,629,253 Cartons.
Sold at
U.S. Nationwide including Puerto Rico.
Description
CGMP Deviations: Firm did not adequately investigate customer complaints.
Product
Azithromycin Tablets, USP, 250 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0961-01), B) 3,500 Count Pouches (NDC: 64679-961-08), and C) 3 x 6 Tablet Card Cartons (NDC: 64679-961-05), 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 →