Class II
Ongoing
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.
This recall is currently active, issued December 6, 2023. It was issued by Apotex Corp..
- Company
- Apotex Corp.
- Recall Initiated
- November 1, 2023
- Posted
- December 6, 2023
- Recall Number
- D-0119-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 34,392
- Firm Location
- Weston, FL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Distribution
Nationwide
Lot / Code Info
Lot numbers: a)100 count bottle: RV2376, RV2377; b) 1000 count bottle: RV2379, RV2380; c) 30 count bottle: RV2375; Exp. 08/2024
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