Apotex Corp.: Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Onta…
| Source | FDA · Drugs (US) |
|---|---|
| Date | 2026-09-02 |
| Product | Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-4379-3 |
| Reason / hazard | Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria |
| Classification | Class II |
| Official notice | — |
| Record ID | fda-drug:D-0804-2026 |