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

FDA recall notice · announced July 19, 2017 · Lupin Pharmaceuticals

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Notes

Distribution: Nationwide in the USA
Lot/code information: Lots: H605712, H605711, H605710, EXP November 2018; H702255, H702202 EXP March 2019
Quantity: 12480 bottles
Status: Terminated
Products in this recall event:
- 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.) 4 (D-0974-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.