Recall: D-0974-2017

Class III - Minor Violations

Class IIIClassification

2017-06-22Initiated

TerminatedStatus

Lupin Pharmaceuticals Inc.Firm

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

Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 month long term stability study.

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.