Drug recall D-0974-2017
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
Reason for recall
Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 month long term stability study.
Lots and codes
Lots: H605712, H605711, H605710, EXP November 2018; H702255, H702202 EXP March 2019
Recall details
- Recalling firm
- Lupin Pharmaceuticals Inc., Baltimore, MD
- Quantity
- 12480 bottles
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- June 22, 2017
- Terminated
- January 17, 2019
Related products
- Paroxetine – drug information
- NDC 68180-645 Paroxetine · Paroxetine Hydrochloride Hemihydrate 37.5 mg/1 · Lupin Pharmaceuticals, Inc.
- NDC 68180-646 Paroxetine · Paroxetine Hydrochloride Hemihydrate 25 mg/1 · Lupin Pharmaceuticals, Inc.
- NDC 68180-647 Paroxetine · Paroxetine Hydrochloride Hemihydrate 12.5 mg/1 · Lupin Pharmaceuticals, Inc.