FDA Drug Class II — Moderate

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 .

Hazard

CGMP Deviations: Firm did not adequately investigate customer complaints.

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 Pa
Brand
Wockhardt Usa Inc.
UPC
A) Lot #: LN11010, Expiry: 4/30/2015; Lot #: LN11011, Expiry: 4/30/2015; Lot #: LN11135, Expiry: 5/31/2015; Lot #: LN11136, Expiry: 5/31/2015; Lot #: LN11137, Expiry: 5/31/2015; Lot #: LN11138, Expiry: 5/31/2015; Lot #: LN11242, Expiry: 6/30/2015; Lot #: LN11243, Expiry: 6/30/2015. B) Lot #: LN11033, Expiry: 4/30/2015; Lot #: LN11034, Expiry: 4/30/2015; Lot #: LN11157, Expiry: 5/31/2015; Lot #: LN11158, Expiry: 5/31/2015; Lot #: LN11159, Expiry: 5/31/2015; Lot #: LN11160, Expiry: 5/31/2015; Lot #: LN11218, Expiry: 5/31/2015; Lot #: LN11219, Expiry: 5/31/2015; Lot #: LN11220, Expiry: 5/31/2015; Lot #: LN11222, Expiry: 6/30/2015; Lot #: LN11403, Expiry: 6/30/2015; Lot #: LN11413, Expiry: 8/31/2015; Lot #: LN11417, Expiry: 8/31/2015; Lot #: LN11418, Expiry: 8/31/2015. C) Lot #: LN10996, Expiry: 4/30/2015; Lot #: LN11172, Expiry: 5/31/2015.

Units Affected

A) 77,967 Bottles, B) 26,785 Bottles, and C) 5,463 Cartons.