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FDA (Drug enforcement)Recalled 2023-11-10closedclass ii

Golden State Medical Supply Inc.: PAROXETINE tablets, USP, 20 mg, Packaged as a) 90-count bottle NDC 60429-735-90; b)1000-count bottle, NDC 60429-735-10; Rx Only, Manufactured by Apotex, Inc., Toronto

Hazard

Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine

Details from the source

Reason for recall: Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine Distribution: Nationwide in the USA Quantity: 2502 bottles Lot/code info: Lot # a) GS036696, GS037068, GS037934, GS038564, Exp. 08/31/2024 b) GS036381, GS036712, GS037116, GS037692, GS038388, Exp. 08/31/2024;

Source

Official record: FDA (Drug enforcement)

Republished from the official source above; details can change — the source record controls.

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