Drug product
Lisinopril Tablets USP, 2.5 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-927-01) and B) 500 Count Bottles (NDC: 64679-927-05), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
D-1244-2015
Product summary
- Event
- Event 71104
- Status
- Terminated
- Classification
- Class II
- Quantity
- A) 149,924 Bottles and B) 35,012 Bottles
- Official record key
drug-enforcement:D-1244-2015
Official wording
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints.
Code information: A) Lot #: DM10573, Expiry: 4/30/2015; Lot #: DM11531, Expiry: 5/31/2015; Lot #: DM11532, Expiry: 5/31/2015; Lot #: DM11676, Expiry: 6/30/2015; Lot #: DM11677, Expiry: 6/30/2015; Lot #: DM12543, Expiry: 8/31/2015; Lot #: DM13333, Expiry: 11/30/2015; Lot #: DN10272, Expiry: 12/31/2015; Lot #: DN10405, Expiry: 12/31/2015; Lot #: DN10446, Expiry: 1/1/2016. B) Lot #: DM11122, Expiry: 4/30/2015; Lot #: DM11130, Expiry: 4/30/2015; Lot #: DM11533, Expiry: 5/31/2015; Lot #: DM11674, Expiry: 6/30/2015; Lot #: DM11675, Expiry: 6/30/2015; Lot #: DM12497, Expiry: 8/31/2015; Lot #: DM13336, Expiry: 11/30/2015; Lot #: DN10289, Expiry: 12/31/2015; Lot #: DN10445, Expiry: 1/31/2016; Lot #: DN10816, Expiry: 1/31/2016; Lot #: DN10817, Expiry: 1/31/2016; Lot #: DN10976, Expiry: 2/29/2016.
Distribution pattern: U.S. Nationwide including Puerto Rico.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations