FDA Recall D-0119-2024

Apotex Corp. · Weston, FL

Class II Ongoing 925 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#: 60505-0097-1; b) 100-count bottle, NDC#: 60505-0097-2; c) 1000-count bottle, NDC#: 60505-0097-4, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.

Lot / code: Lot numbers: a)100 count bottle: RV2376, RV2377; b) 1000 count bottle: RV2379, RV2380; c) 30 count bottle: RV2375; Exp. 08/2024

Quantity: 34,392

Reason for recall

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

Recall record

Recall number: D-0119-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: Nationwide
Recall initiated: 2023-11-01
Classified by FDA Center: 2023-11-27
FDA published: 2023-12-06
Recalling firm: Apotex Corp.
Firm location: Weston, FL

Drug identification

Brand name(s): PAROXETINE
Generic name(s): PAROXETINE HYDROCHLORIDE
Manufacturer(s): Apotex Corp.
NDC(s): 60505-0083, 60505-0097, 60505-0084, 60505-0101
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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