Drug product
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.
D-0119-2024
Product summary
- Firm
- Apotex Corp.
- Event
- Event 93353
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 34,392
- Official record key
drug-enforcement:D-0119-2024
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: RV2376, RV2377; b) 1000 count bottle: RV2379, RV2380; c) 30 count bottle: RV2375; Exp. 08/2024
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Out of specification