Drug product
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.
D-0121-2024
Product summary
- Firm
- Apotex Corp.
- Event
- Event 93353
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 25,776
- Official record key
drug-enforcement:D-0121-2024
Official wording
Reason: Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Code information: Lot numbers: a)100 count bottle: RV8686; b) 1000 count bottle: RX0119; c) 30 count bottle: RV2254; Exp. 08/2024
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Out of specification