Reported Jul 19, 2017 · Terminated
Paroxetine Extended-Release Tablets USP, 12.5 mg, 30 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals,…
Lupin Pharmaceuticals Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Lupin Pharmaceuticals Inc. · 111 S Calvert St Fl 21ST · Baltimore, MD · 21202-6174
Is this the product you have?
- Paroxetine Extended-Release Tablets USP, 12.5 mg, 30 count bottle, Rx only
- Manufactured forLupin Pharmaceuticals, Inc. Baltimore, Maryland, 21202
- Manufactured byLupin Limited, Pithampur (M.P.) 454 775, India
- NDC68180-647-06
- Lot codes and dates
- Lots
H605712H605711H605710EXP November 2018H702255H702202 EXP March 2019
- Lots
- Amount recalled
- 12480 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 month long term stability study.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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