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Recall Observatory FDA recall evidence

Drug product

Paroxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#:60505-0101-4 Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.

D-0122-2024

November 01, 2023

Class II

Product summary

Firm
Apotex Corp.
Event
Event 93353
Status
Ongoing
Classification
Class II
Quantity
4,074
Official record key
drug-enforcement:D-0122-2024

Official wording

Reason: Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine

Code information: Lot numbers: RV0131, RV2387, RV2389, RW3296, RV2388; Exp. 08/2024

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out of specification