Why it was recalled
Failed Dissolution Specifications: Drug release test result, obtained during routine 9-month stability testing, which was below specification for one tablet. Teva cannot at this time exclude the potential for additional tablets to be below specification.
Product description
Paliperidone Extended-Release Tablets, 3 mg, 90 count bottles, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA, NDC: 0591-3693-19
Lot numbers, UPCs & expiration codes
Lot: 1160682A, EXP. 06/18
Where it was sold
Nationwide in the US
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-0960-2017
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- May 31, 2017
- FDA report date
- Jul 19, 2017
- Quantity
- 360 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-0960-2017, exactly as published.
Show all FDA fields
- City
- Horsham
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 77393
- Address
- 425 Privet Rd
- Code information
- Lot: 1160682A, EXP. 06/18
- Postal code
- 19044-1220
- Report date
- Jul 19, 2017
- Product type
- Drugs
- Recall number
- D-0960-2017
- Classification
- Class I
- Recalling firm
- Teva Pharmaceuticals
- Product quantity
- 360 bottles
- Termination date
- Mar 29, 2018
- Reason for recall
- Failed Dissolution Specifications: Drug release test result, obtained during routine 9-month stability testing, which was below specification for one tablet. Teva cannot at this time exclude the potential for additional tablets to be below specification.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Paliperidone Extended-Release Tablets, 3 mg, 90 count bottles, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA, NDC: 0591-3693-19
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- May 31, 2017
- Initial firm notification
- Letter
- Center classification date
- Jul 11, 2017