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FDARecalled Sep 2, 2026 · #D-0804-2026

Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 333...

Hazard

Class II — temporary health risk

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Description

Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria Classification: Class II Distribution: US Nationwide.

Product details

Product
Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-4379-3
Type
Drugs
Manufacturer
Apotex Corp.
Model numbers
TY9494
UPCs
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