Why it was recalled
Some bottles may contain mixed strengths of the product.
Product description
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed Amphetamine Salts Product), 15 mg, 100 count bottles, Rx Only, Teva Pharmaceuticals USA, INC. North Wales, PA 19454, NDC 0555-0777-02
Lot numbers, UPCs & expiration codes
Lot #: 42617008, Exp. date 10/2021
Where it was sold
Nationwide within the United State 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-1286-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 22, 2020
- FDA report date
- Jun 10, 2020
- Quantity
- 41,348 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-1286-2020, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 85712
- Address
- 400 Interpace Pkwy
- Code information
- Lot #: 42617008, Exp. date 10/2021
- Postal code
- 07054-1120
- Report date
- Jun 10, 2020
- Product type
- Drugs
- Recall number
- D-1286-2020
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 41,348 bottles
- Termination date
- May 25, 2021
- Reason for recall
- Some bottles may contain mixed strengths of the product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed Amphetamine Salts Product), 15 mg, 100 count bottles, Rx Only, Teva Pharmaceuticals USA, INC. North Wales, PA 19454, NDC 0555-0777-02
- Distribution pattern
- Nationwide within the United State and Puerto Rico.
- Recall initiation date
- May 22, 2020
- Initial firm notification
- Letter
- Center classification date
- Jun 4, 2020