Drug product
Lisinopril Tablets USP, 30 mg, packaged in a) 500-count bottles (NDC 68180-516-02) and b) 100-count bottles (NDC 68180-516-01); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA.
D-1502-2016
Product summary
- Event
- Event 74945
- Status
- Terminated
- Classification
- Class III
- Quantity
- 20,556 bottles
- Official record key
drug-enforcement:D-1502-2016
Official wording
Reason: CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Code information: Batch number: H303487, H303488, H303489, Exp 09/16
Distribution pattern: All product distributed domestically in the US. No recalled product was distributed to U.S. Government Agency consignees directly by Lupin. No recalled product was distributed to any foreign consignees by Lupin.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations