FDAFDA · Food and drugs·Recall number D-0121-2024
Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#: 60505-0084-1, b)100-count bottle, NDC#:60505-0084-2, c)1000-count bottle, NDC#: 60505-0084-4, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.
Published December 6, 2023 · Recall initiated: November 1, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Brand
- PAROXETINE
- Manufacturer
- Apotex Corp.
- Distributor
- Nationwide
- UPC
- 0360505010110
- Lot
- Lot numbers: a)100 count bottle: RV8686; b) 1000 count bottle: RX0119; c) 30 count bottle: RV2254; Exp. 08/2024
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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