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.
Recall initiated: 20170622
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated