Why it was recalled
Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets
Product description
Paroxetine Tablets USP, 30 mg, a) 30 count (NDC 68382-099-06), b) 500 count (NDC 68382-099-05), and c) 1000 count (NDC 68382-099-10) count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534
Lot numbers, UPCs & expiration codes
a) Z701308, b) Z701309, c) Z701310 exp April 2019
Where it was sold
Nationwide
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-0101-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 20, 2017
- FDA report date
- Dec 6, 2017
- Quantity
- 19812 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Zydus Pharmaceuticals USA Inc
Original FDA data
Every field from FDA enforcement report D-0101-2018, exactly as published.
Show all FDA fields
- City
- Pennington
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 78612
- Address
- 73 Route 31 N
- Code information
- a) Z701308, b) Z701309, c) Z701310 exp April 2019
- Postal code
- 08534-3601
- Report date
- Dec 6, 2017
- Product type
- Drugs
- Recall number
- D-0101-2018
- Classification
- Class II
- Recalling firm
- Zydus Pharmaceuticals USA Inc
- Product quantity
- 19812 bottles
- Termination date
- Sep 1, 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, 30 mg, a) 30 count (NDC 68382-099-06), b) 500 count (NDC 68382-099-05), and c) 1000 count (NDC 68382-099-10) count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534
- Distribution pattern
- Nationwide
- Recall initiation date
- Nov 20, 2017
- Initial firm notification
- Letter
- Center classification date
- Nov 30, 2017