Recalls / Class II
Class IID-0121-2024
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.
- Brand name
- Paroxetine
- Generic name
- Paroxetine Hydrochloride
- Active ingredient
- Paroxetine Hydrochloride Anhydrous
- Route
- Oral
- NDCs
- 60505-0083, 60505-0097, 60505-0084, 60505-0101
- FDA application
- ANDA075356
- Affected lot / code info
- Lot numbers: a)100 count bottle: RV8686; b) 1000 count bottle: RX0119; c) 30 count bottle: RV2254; Exp. 08/2024
Why it was recalled
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Recalling firm
- Firm
- Apotex Corp.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 2400 N Commerce Pkwy Ste 400, Weston, Florida 33326-3253
Distribution
- Quantity
- 25,776
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2023-11-01
- FDA classified
- 2023-11-27
- Posted by FDA
- 2023-12-06
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0121-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.