Recalls / Class II
Class IID-1448-2016
Product
Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, 90- count bottles, Rx Only Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA; Distributed by: Actavis Pharma, Inc Parsippany, NJ 07054 USA NDC 45963-304-09
- 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 #: 3803J141, Exp. 7/2016
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Actavis Inc
- Manufacturer
- Actavis Pharma, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy, N/A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 8,062 units
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-07-11
- FDA classified
- 2016-07-26
- Posted by FDA
- 2016-08-03
- Terminated
- 2017-02-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1448-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.