Why it was recalled
Failed Impurities/Degradation Specifications: out of specification for unknown impurity
Product description
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, (CII), 10 mg (Mixed Salts of a Single Entity Amphetamine Product), 100 count bottles, manufactured at Barr Laboratories, Inc. Forest, VA for Teva Pharmaceuticals USA, Sellersville, PA --- NDC 0555-0972-02
Lot numbers, UPCs & expiration codes
Lot #: 34015862A, Exp. Date 6/2016 Lot #: 34016376A, Exp. Date 7/2016
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-1283-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 24, 2015
- FDA report date
- Aug 12, 2015
- Quantity
- 19,504 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-1283-2015, exactly as published.
Show all FDA fields
- City
- Horsham
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 71594
- Address
- 425 Privet Rd
- Code information
- Lot #: 34015862A, Exp. Date 6/2016 Lot #: 34016376A, Exp. Date 7/2016
- Postal code
- 19044-1220
- Report date
- Aug 12, 2015
- Product type
- Drugs
- Recall number
- D-1283-2015
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 19,504 bottles
- Termination date
- Aug 17, 2016
- Reason for recall
- Failed Impurities/Degradation Specifications: out of specification for unknown impurity
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, (CII), 10 mg (Mixed Salts of a Single Entity Amphetamine Product), 100 count bottles, manufactured at Barr Laboratories, Inc. Forest, VA for Teva Pharmaceuticals USA, Sellersville, PA --- NDC 0555-0972-02
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 24, 2015
- Initial firm notification
- Letter
- Center classification date
- Aug 3, 2015