D-0119-2024 Class II Ongoing
FDA drug recall D-0119-2024 was initiated by Apotex Corp. on Nov 1, 2023 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine The recall status is ongoing. Affected quantity: 34,392.
Recall details
- Product Type
- Drugs
- Report Date
- Dec 6, 2023
- Initiation Date
- Nov 1, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 34,392
Product description
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.
Reason for recall
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Distribution pattern
Nationwide
Code information
Lot numbers: a)100 count bottle: RV2376, RV2377; b) 1000 count bottle: RV2379, RV2380; c) 30 count bottle: RV2375; Exp. 08/2024
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0119-2024
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026