Apotex Corp.: Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L
Read the official notice at FDA (drug) →
The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- Apotex Corp.
- 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
- Status
- Ongoing
- Distribution / sold at
- US Nationwide.
- Recall initiated
- 2026-08-13
- Code info
- Lot # TY9494, Exp Date: 05/31/2027.
- Product quantity
- 6,972 bottles
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Weston
- State
- FL
- Country
- United States
- Event id
- 99673
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