Drug product
Lisinopril & Hydrochlorothiazide Tables, USP 20mg/12.5mg, packaged in a)100-count bottles and b) 5000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 India, a) NDC 68180-519-01, b) 68180-519-30
D-1052-2016
Product summary
- Event
- Event 73848
- Status
- Terminated
- Classification
- Class III
- Quantity
- 59,520 Bottles
- Official record key
drug-enforcement:D-1052-2016
Official wording
Reason: CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Code information: Lot #: a) H303459, b) H303460, Exp 09/2016
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Manufacturing or process control
CGMP Deviations