Why it was recalled
Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing.
Product description
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets (Mixed Salts of a Single Entity Amphetamine Product), 10 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0972-02, UPC 3 0555-0972-02 0.
Lot numbers, UPCs & expiration codes
Lot #: 34015516A, Exp 05/16
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-0566-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 12, 2015
- FDA report date
- Jan 20, 2016
- Quantity
- 9,717 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0566-2016, exactly as published.
Show all FDA fields
- City
- North Wales
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 72988
- Address
- 1090 Horsham Rd
- Code information
- Lot #: 34015516A, Exp 05/16
- Postal code
- 19454-1505
- Report date
- Jan 20, 2016
- Product type
- Drugs
- Recall number
- D-0566-2016
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 9,717 bottles
- Termination date
- Nov 1, 2016
- Reason for recall
- Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets (Mixed Salts of a Single Entity Amphetamine Product), 10 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0972-02, UPC 3 0555-0972-02 0.
- Distribution pattern
- Nationwide
- Recall initiation date
- Nov 12, 2015
- Initial firm notification
- Letter
- Center classification date
- Jan 11, 2016