Why it was recalled
Presence of Foreign tablets/capsules: risperidone Tablets were found in bottle of paroxetine Tablets
Product description
Paroxetine tablets USP, 30mg, 30-count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534, NDC 68382-099-06, UPC 3 6838209906 8
Lot numbers, UPCs & expiration codes
Lot #: Z701133, Exp 03/19
Where it was sold
Nationwide within United States
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-1137-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 18, 2017
- FDA report date
- Sep 20, 2017
- Quantity
- 44800 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Zydus Pharmaceuticals USA Inc
Original FDA data
Every field from FDA enforcement report D-1137-2017, exactly as published.
Show all FDA fields
- City
- Pennington
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 77963
- Address
- 73 Route 31 N
- Code information
- Lot #: Z701133, Exp 03/19
- Postal code
- 08534-3601
- Report date
- Sep 20, 2017
- Product type
- Drugs
- Recall number
- D-1137-2017
- Classification
- Class II
- Recalling firm
- Zydus Pharmaceuticals USA Inc
- Product quantity
- 44800 bottles
- Termination date
- Jan 6, 2020
- Reason for recall
- Presence of Foreign tablets/capsules: risperidone Tablets were found in bottle of paroxetine Tablets
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Paroxetine tablets USP, 30mg, 30-count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534, NDC 68382-099-06, UPC 3 6838209906 8
- Distribution pattern
- Nationwide within United States
- Recall initiation date
- Aug 18, 2017
- Initial firm notification
- Letter
- Center classification date
- Sep 11, 2017