FDA-Drug2015-07-29Class II

Metoprolol Succinate Extended-Release Tablets, USP, 100 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0736-02), B) 500 Count Bottles (NDC: 64679-0736-03), and C) 12 x 30 Tablet Dispenser Pack Cartons (NDC: 64679-0736-09), 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) 77,967 Bottles, B) 26,785 Bottles, and C) 5,463 Cartons.
Manufactured in
20 Waterview Blvd Ste 3, N/A, Parsippany, NJ, United States
Products
Metoprolol Succinate Extended-Release Tablets, USP, 100 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0736-02), B) 500 Count Bottles (NDC: 64679-0736-03), and C) 12 x 30 Tablet Dispenser Pack Cartons (NDC: 64679-0736-09), 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-1270-2015

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