Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification for unknown impurities.
Product description
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets, (CII), 10 mg, 100 Tablet Bottles, Rx Only. Teva Pharmaceuticals USA , Sellersville, PA 18960, NDC: 0555-0972-02. 0555-0972-02, lot #s 34016373A, 34016377A, exp. dated 7/2016.
Lot numbers, UPCs & expiration codes
Lot #: 34016373A, Expiry: 7/2016; Lot #: 34016377A, Expiry: 7/2016.
Where it was sold
U.S. Nationwide including Puerto Rico.
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-0050-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 8, 2014
- FDA report date
- Nov 5, 2014
- Quantity
- 19,545 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0050-2015, exactly as published.
Show all FDA fields
- City
- Horsham
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 69483
- Address
- 425 Privet Rd
- Code information
- Lot #: 34016373A, Expiry: 7/2016; Lot #: 34016377A, Expiry: 7/2016.
- Postal code
- 19044-1220
- Report date
- Nov 5, 2014
- Product type
- Drugs
- Recall number
- D-0050-2015
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 19,545 Bottles
- Termination date
- Sep 21, 2015
- Reason for recall
- Failed Impurities/Degradation Specifications: Out of specification for unknown impurities.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets, (CII), 10 mg, 100 Tablet Bottles, Rx Only. Teva Pharmaceuticals USA , Sellersville, PA 18960, NDC: 0555-0972-02. 0555-0972-02, lot #s 34016373A, 34016377A, exp. dated 7/2016.
- Distribution pattern
- U.S. Nationwide including Puerto Rico.
- Recall initiation date
- Oct 8, 2014
- Initial firm notification
- Letter
- Center classification date
- Oct 27, 2014