Why it was recalled
Labeling: Label Error on Declared Strength; A sealed 100-count bottle labeled with 15 mg actually contained 100 tablets of 20 mg strength of the drug product.
Product description
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product), 15 mg, Rx Only, 100 tablets per bottle, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0555-0777-02.
Lot numbers, UPCs & expiration codes
Lot #: 100023340, Exp 10/2024
Where it was sold
Nationwide in the US.
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-1539-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 29, 2022
- FDA report date
- Sep 21, 2022
- Quantity
- 83,703 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA Inc
Original FDA data
Every field from FDA enforcement report D-1539-2022, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 90803
- Address
- 400 Interpace Pkwy Bldg A
- Code information
- Lot #: 100023340, Exp 10/2024
- Postal code
- 07054-1120
- Report date
- Sep 21, 2022
- Product type
- Drugs
- Recall number
- D-1539-2022
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA Inc
- Product quantity
- 83,703 bottles
- Termination date
- Aug 14, 2023
- Reason for recall
- Labeling: Label Error on Declared Strength; A sealed 100-count bottle labeled with 15 mg actually contained 100 tablets of 20 mg strength of the drug product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product), 15 mg, Rx Only, 100 tablets per bottle, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0555-0777-02.
- Distribution pattern
- Nationwide in the US.
- Recall initiation date
- Aug 29, 2022
- Initial firm notification
- Letter
- Center classification date
- Sep 16, 2022