Drug product
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 .
D-1270-2015
Product summary
- Event
- Event 71104
- Status
- Terminated
- Classification
- Class II
- Quantity
- A) 77,967 Bottles, B) 26,785 Bottles, and C) 5,463 Cartons.
- Official record key
drug-enforcement:D-1270-2015
Official wording
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints.
Code information: 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.
Distribution pattern: U.S. Nationwide including Puerto Rico.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations