Recalls / Class II
Class IID-1408-2014
Product
Dextroamphetamine Sulfate Tablets, USP, 10 mg, 100-count bottles, Rx only, Barr Laboratories, Inc., Pomona, NY 10970, NDC 0555-0953-02.
- Brand name
- Dextroamphetamine Sulfate
- Generic name
- Dextroamphetamine Sulfate
- Active ingredient
- Dextroamphetamine Sulfate
- Route
- Oral
- NDCs
- 0555-0952, 0555-0953
- FDA application
- ANDA040361
- Affected lot / code info
- Lot # 34013122A, Exp 11/15
Why it was recalled
Failed Impurities/Degradation Specifications: this product is being recalled due to an out of specification test result for impurities during stability testing.
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
- 9,882 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2014-05-01
- FDA classified
- 2014-06-23
- Posted by FDA
- 2014-07-02
- Terminated
- 2014-12-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1408-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.