Recalls / Class II
Class IID-1539-2022
Product
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.
- Brand name
- Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate
- Generic name
- Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate
- Active ingredients
- Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate
- Route
- Oral
- NDCs
- 0555-0775, 0555-0971, 0555-0972, 0555-0776, 0555-0777, 0555-0973, 0555-0974
- FDA application
- ANDA040422
- Affected lot / code info
- Lot #: 100023340, Exp 10/2024
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.
Recalling firm
- Firm
- Teva Pharmaceuticals USA Inc
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy Bldg A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 83,703 bottles
- Distribution pattern
- Nationwide in the US.
Timeline
- Recall initiated
- 2022-08-29
- FDA classified
- 2022-09-16
- Posted by FDA
- 2022-09-21
- Terminated
- 2023-08-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1539-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.