FDA 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.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2017-06-22

Report date

2017-07-19

Termination date

2019-01-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0974-2017