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Medicine / D-0804-2026

U.S. Food and Drug AdministrationD-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…

Class II Distributed nationwide or U.S.-wide Status: Ongoing

What was recalled

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

Recalling firm

Apotex Corp.

Reason for recall

Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria

Where it went

US Nationwide.

Shown as U.S. Food and Drug Administration published it (shortened where marked …). Recall Shelf does not change recall facts and is not affiliated with the agency.