Why it was recalled
Failed Impurities/Degradation Specifications: this product is being recalled due to an out of specification test result for impurities during stability testing.
Product description
Dextroamphetamine Sulfate Tablets, USP, 10 mg, 100-count bottles, Rx only, Barr Laboratories, Inc., Pomona, NY 10970, NDC 0555-0953-02.
Lot numbers, UPCs & expiration codes
Lot # 34013122A, Exp 11/15
Where it was sold
Nationwide and 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-1408-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 1, 2014
- FDA report date
- Jul 2, 2014
- Quantity
- 9,882 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-1408-2014, exactly as published.
Show all FDA fields
- City
- Horsham
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 68225
- Address
- 425 Privet Rd
- Code information
- Lot # 34013122A, Exp 11/15
- Postal code
- 19044-1220
- Report date
- Jul 2, 2014
- Product type
- Drugs
- Recall number
- D-1408-2014
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 9,882 bottles
- Termination date
- Dec 9, 2014
- Reason for recall
- Failed Impurities/Degradation Specifications: this product is being recalled due to an out of specification test result for impurities during stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Dextroamphetamine Sulfate Tablets, USP, 10 mg, 100-count bottles, Rx only, Barr Laboratories, Inc., Pomona, NY 10970, NDC 0555-0953-02.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- May 1, 2014
- Initial firm notification
- Letter
- Center classification date
- Jun 23, 2014