Recalls / Class II
Class IID-1283-2015
Product
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, (CII), 10 mg (Mixed Salts of a Single Entity Amphetamine Product), 100 count bottles, manufactured at Barr Laboratories, Inc. Forest, VA for Teva Pharmaceuticals USA, Sellersville, PA --- NDC 0555-0972-02
- 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 #: 34015862A, Exp. Date 6/2016 Lot #: 34016376A, Exp. Date 7/2016
Why it was recalled
Failed Impurities/Degradation Specifications: out of specification for unknown impurity
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 425 Privet Rd, N/A, Horsham, Pennsylvania 19044-1220
Distribution
- Quantity
- 19,504 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-06-24
- FDA classified
- 2015-08-03
- Posted by FDA
- 2015-08-12
- Terminated
- 2016-08-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1283-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.