Drug product
Paroxetine Extended-Release Tablets USP, 12.5 mg, 30 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland, 21202, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC: 68180-647-06
D-0974-2017
Product summary
- Event
- Event 77606
- Status
- Terminated
- Classification
- Class III
- Quantity
- 12480 bottles
- Official record key
drug-enforcement:D-0974-2017
Official wording
Reason: Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 month long term stability study.
Code information: Lots: H605712, H605711, H605710, EXP November 2018; H702255, H702202 EXP March 2019
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
out of specification