Drug product
Metoprolol Succinate Extended-Release Tablets, USP, 25 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0734-02), B) 500 Count Bottles (NDC: 64679-0734-03), C) 8000 Count Pouches, For Repacking Only (NDC: 64679-734-08) and D) 12 x 30 Tablet Dispenser Pack Cartons (NDC: 64679-0734-09), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
D-1272-2015
Product summary
- Event
- Event 71104
- Status
- Terminated
- Classification
- Class II
- Quantity
- A) 132,409 Bottles, B) 41,257 Bottles, C) 576 Pouches, and D) 6,429 Cartons.
- Official record key
drug-enforcement:D-1272-2015
Official wording
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints.
Code information: A) Lot #: LN11050, Expiry: 4/30/2015; Lot #: LN11053, Expiry: 4/30/2015; Lot #: LN11169, Expiry: 5/31/2015; Lot #: LN11312, Expiry: 6/30/2015; Lot #: LN11313, Expiry: 6/30/2015; Lot #: LN11318, Expiry: 6/30/2015. B) Lot #: LN11030, Expiry: 4/30/2015; Lot #: LN11031, Expiry: 4/30/2015; Lot #: LN11032, Expiry: 4/30/2015; Lot #: LN11038, Expiry: 4/30/2015; Lot #: LN11042, Expiry; 4/30/2015; Lot #: LN11047, Expiry: 4/30/2015; Lot #: LN11173, Expiry: 5/31/2015; Lot #: LN11289, Expiry: 6/30/2015; Lot #: LN11293, Expiry: 6/30/2015. C) Lot #: LN11185, Expiry: 5/31/2015; Lot #: LN11190, Expiry: 5/31/2015. D) Lot #: LN11180, Expiry: 5/31/2015.
Distribution pattern: U.S. Nationwide including Puerto Rico.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations