Drug product
Lisinopril Tablets, USP, 30 mg, Rx only, 100 tablets, NDC 65862-041-01 Manufactured for: Aurobindo Pharma USA Inc. 2400 Route 130 North, Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Hyderabad- 500 072 India
D-498-2013
Product summary
- Event
- Event 65071
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1776 bottles
- Official record key
drug-enforcement:D-498-2013
Official wording
Reason: Labeling: Label Error on Declared Strength: Incorrect strength on side display panel of label
Code information: Lot KP3012001-A Exp.12/13 Lot KP3012002-A Exp.12/13
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Label Error
-
Potency or specification failure
Incorrect strength