FDA-Drug2015-07-29Class II
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.
Wockhardt Usa Inc.
Hazard
CGMP Deviations: Firm did not adequately investigate customer complaints.
Sold states
U.S. Nationwide including Puerto Rico.
Affected count
A) 280,520 Bottles, B) 571 Pouches, and C) 1,629,253 Cartons.
Manufactured in
20 Waterview Blvd Ste 3, N/A, Parsippany, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1248-2015Don't want to check this manually?
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