Recalls / Class II
Class IID-0395-2015
Product
Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg, 90-count bottles, Rx Only, Manufactured by: Actavis Elizabeth LLC, Elizabeth, NJ 07201 USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA; NDC 45963-305-09, UPC 3 45963-305-09 1.
- Brand name
- Dextroamphetamine Sulfate
- Generic name
- Dextroamphetamine Sulfate
- Active ingredient
- Dextroamphetamine Sulfate
- Route
- Oral
- NDCs
- 45963-303, 45963-304, 45963-305
- FDA application
- ANDA203901
- Affected lot / code info
- Lot #: 2020E141, Exp 07/15
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Actavis Elizabeth LLC
- Manufacturer
- Actavis Pharma, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 200 Elmora Ave, N/A, Elizabeth, New Jersey 07202-1106
Distribution
- Quantity
- 42 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-02-10
- FDA classified
- 2015-02-27
- Posted by FDA
- 2015-03-11
- Terminated
- 2015-08-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0395-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.