Why it was recalled
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Product description
Paroxetine HCL Controlled-Release Tablets 37.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3675-3
Lot numbers, UPCs & expiration codes
Lot # 2C002, Exp. 03/15 Lot # 2H004, Exp. 08/15 Lot # 2H006, Exp. 08/15
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1577-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 24, 2014
- FDA report date
- Sep 10, 2014
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apotex Inc.
Original FDA data
Every field from FDA enforcement report D-1577-2014, exactly as published.
Show all FDA fields
- City
- Toronto
- Status
- Terminated
- Country
- Canada
- Event ID
- 68967
- Address
- 150 Signet Drive
- Code information
- Lot # 2C002, Exp. 03/15 Lot # 2H004, Exp. 08/15 Lot # 2H006, Exp. 08/15
- Report date
- Sep 10, 2014
- Product type
- Drugs
- Recall number
- D-1577-2014
- Classification
- Class II
- Recalling firm
- Apotex Inc.
- Termination date
- Sep 23, 2014
- Reason for recall
- Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Paroxetine HCL Controlled-Release Tablets 37.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3675-3
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Mar 24, 2014
- Initial firm notification
- Letter
- Center classification date
- Sep 3, 2014