Recalls / Class II
Class IID-1287-2020
Product
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed Amphetamine Salts Product), 20 mg, 100 count bottles, Rx Only, Teva Pharmaceuticals USA, INC. North Wales, PA 19454, NDC 0555-0973-02
- 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 #: 42617891, exp. date 01/2022
Why it was recalled
Some bottles may contain mixed strengths of the product.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy, N/A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 84,209 bottles
- Distribution pattern
- Nationwide within the United State and Puerto Rico.
Timeline
- Recall initiated
- 2020-05-22
- FDA classified
- 2020-06-04
- Posted by FDA
- 2020-06-10
- Terminated
- 2021-05-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1287-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.