Class III
Terminated
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
This recall has been terminated (originally issued July 19, 2017).
- Company
- Lupin Pharmaceuticals Inc.
- Recall Initiated
- June 22, 2017
- Posted
- July 19, 2017
- Recall Number
- D-0974-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 12480 bottles
- Firm Location
- Baltimore, MD, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 month long term stability study.
Distribution
Nationwide in the USA
Lot / Code Info
Lots: H605712, H605711, H605710, EXP November 2018; H702255, H702202 EXP March 2019
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