Drug product
Paroxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#:60505-0101-4 Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.
D-0122-2024
Product summary
- Firm
- Apotex Corp.
- Event
- Event 93353
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4,074
- Official record key
drug-enforcement:D-0122-2024
Official wording
Reason: Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Code information: Lot numbers: RV0131, RV2387, RV2389, RW3296, RV2388; Exp. 08/2024
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Out of specification