Why it was recalled
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Product description
Paliperidone Extended Release Tablets 3 mg, packaged in a) 30-count bottle(NDC 0591-3693-30), b) 90-count bottle (NDC-0591-3693-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054
Lot numbers, UPCs & expiration codes
Lot #: a) 1220221A, Exp 03/2019; 1269627A, Exp 09/2019; 1274295A, Exp 10/2019; b) 1220222A, Exp 03/2019; 1270501A, Exp 09/2019; 1274296A, Exp 10/2019; 1288766A, Exp 01/2020
Where it was sold
Product was distributed throughout the United States. Bulk product was distributed to Takeda, Deerfield, IL and may have been further distributed.
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-0096-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 6, 2018
- FDA report date
- Oct 31, 2018
- Quantity
- 27,816 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0096-2019, exactly as published.
Show all FDA fields
- City
- North Wales
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 80790
- Address
- 1090 Horsham Rd
- Code information
- Lot #: a) 1220221A, Exp 03/2019; 1269627A, Exp 09/2019; 1274295A, Exp 10/2019; b) 1220222A, Exp 03/2019; 1270501A, Exp 09/2019; 1274296A, Exp 10/2019; 1288766A, Exp 01/2020
- Postal code
- 19454-1505
- Report date
- Oct 31, 2018
- Product type
- Drugs
- Recall number
- D-0096-2019
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 27,816 bottles
- Termination date
- Feb 13, 2020
- Reason for recall
- Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Paliperidone Extended Release Tablets 3 mg, packaged in a) 30-count bottle(NDC 0591-3693-30), b) 90-count bottle (NDC-0591-3693-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054
- Distribution pattern
- Product was distributed throughout the United States. Bulk product was distributed to Takeda, Deerfield, IL and may have been further distributed.
- Recall initiation date
- Aug 6, 2018
- Initial firm notification
- Letter
- Center classification date
- Oct 25, 2018