ownitsafely
Back to recalls

FDARecalled Dec 6, 2023 · #D-0121-2024

Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#: 60505-0084-1, b)100-count bottle, NDC#:60505-0084-2, c)1000-count bottle, NDC#: 60505-0084-4, Manufactured by: Apotex ...

Hazard

Class II — temporary health risk

Be the first to hear about future recalls.

Add the things you own to a watchlist. We’ll alert you the moment one matches.

Get started, free

Description

Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine Classification: Class II Distribution: Nationwide

Product details

Product
Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#: 60505-0084-1, b)100-count bottle, NDC#:60505-0084-2, c)1000-count bottle, NDC#: 60505-0084-4, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.
Type
Drugs
Manufacturer
Apotex Corp.
Model numbers
numbers
UPCs