Drug recall D-0120-2024
Product
Paroxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle, NDC#:60505-0083-2; b) 1000-count bottle, NDC#: 60505-0083-4 Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.
Reason for recall
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Lots and codes
Lot numbers: a)100 count bottle: RV2384, RV2385; b) 1000 count bottle: RV2396, RV2397; Exp. 08/2024
Recall details
- Recalling firm
- Apotex Corp., Weston, FL
- Quantity
- 48,623
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- November 1, 2023
Related products
- Paroxetine – drug information
- NDC 60505-0083 Paroxetine · Paroxetine Hydrochloride Anhydrous 20 mg/1 · Apotex Corp.
- NDC 60505-0097 Paroxetine · Paroxetine Hydrochloride Anhydrous 10 mg/1 · Apotex Corp.
- NDC 60505-0101 Paroxetine · Paroxetine Hydrochloride Anhydrous 40 mg/1 · Apotex Corp.
- NDC 60505-0084 Paroxetine · Paroxetine Hydrochloride Anhydrous 30 mg/1 · Apotex Corp.