Drug product
Metoprolol Succinate Extended-Release Tablets, USP, 200 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0737-02) and B) 500 Count Bottles (NDC: 64679-0737-03), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA .
D-1252-2015
Product summary
- Event
- Event 71104
- Status
- Terminated
- Classification
- Class II
- Quantity
- A) 33,422 Bottles and B) 940 Bottles.
- Official record key
drug-enforcement:D-1252-2015
Official wording
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints.
Code information: A) Lot #: LN10978, Expiry: 4/30/2015; Lot #: LN11007, Expiry: 4/30/2015; Lot #: LN11013, Expiry: 4/30/2015; Lot #: LN11258, Expiry: 6/30/2015; Lot #: LN11259, Expiry: 6/30/2015; Lot #: LN11277, Expiry: 6/30/2015; Lot #: LN11317, Expiry: 6/30/2015. B) Lot #: LN11255, Expiry: 6/30/2015.
Distribution pattern: U.S. Nationwide including Puerto Rico.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations