Recalls / Class III
Class IIID-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
- Brand name
- Paroxetine
- Generic name
- Paroxetine
- Active ingredient
- Paroxetine Hydrochloride Hemihydrate
- Route
- Oral
- NDCs
- 68180-645, 68180-647, 68180-646
- FDA application
- ANDA204134
- Affected lot / code info
- Lots: H605712, H605711, H605710, EXP November 2018; H702255, H702202 EXP March 2019
Why it was recalled
Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 month long term stability study.
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 111 S Calvert St Fl 21ST, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 12480 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2017-06-22
- FDA classified
- 2017-07-12
- Posted by FDA
- 2017-07-19
- Terminated
- 2019-01-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0974-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.