FDAFDA · Food and drugs·Recall number D-0119-2024
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.
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: RV2376, RV2377; b) 1000 count bottle: RV2379, RV2380; c) 30 count bottle: RV2375; Exp. 08/2024
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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