Drug product
Lisinopril tablets, 5 mg, 1000-count bottle, Rx only, Manufactured for Accord Healthcare, Inc., Durham, NC 27703, NDC 16729-376-17
D-0478-2017
Product summary
- Event
- Event 76105
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12896 bottles
- Official record key
drug-enforcement:D-0478-2017
Official wording
Reason: Failed tablet/capsule specification: missing break line on the 5mg tablet.
Code information: Lot # T04483, T04484, Exp 2/18; T06028, Exp 4/18; T08423, Exp 5/18
Distribution pattern: U.S. Nationwide and Puerto Rico
Derived failure modes
-
Unknown
Failed tablet/capsule specification: missing break line on the 5mg tablet.