Why it was recalled
CGMP Deviations: Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg were manufactured using unapproved material: the finished product was not properly quarantined as rejected due to inadequate cleaning of equipment.
Product description
Teva Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg (mixed salts) , 100 count-bottle, Rx Only, Distributed by Teva Pharmaceuticals, USA, Sellersville, PA. NDC 0555-0972-02.
Lot numbers, UPCs & expiration codes
Lot # 34017575A, Exp. 10/16.
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-1094-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 24, 2014
- FDA report date
- Mar 12, 2014
- Quantity
- 9796 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-1094-2014, exactly as published.
Show all FDA fields
- City
- Horsham
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 67412
- Address
- 425 Privet Rd
- Code information
- Lot # 34017575A, Exp. 10/16.
- Postal code
- 19044-1220
- Report date
- Mar 12, 2014
- Product type
- Drugs
- Recall number
- D-1094-2014
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 9796 tablets
- Termination date
- Oct 8, 2014
- Reason for recall
- CGMP Deviations: Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg were manufactured using unapproved material: the finished product was not properly quarantined as rejected due to inadequate cleaning of equipment.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Teva Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg (mixed salts) , 100 count-bottle, Rx Only, Distributed by Teva Pharmaceuticals, USA, Sellersville, PA. NDC 0555-0972-02.
- Distribution pattern
- Nationwide.
- Recall initiation date
- Jan 24, 2014
- Initial firm notification
- Letter
- Center classification date
- Feb 28, 2014