D-1448-2016 Class II Terminated
FDA drug recall D-1448-2016 was initiated by Actavis Inc on July 11, 2016 and is designated Class II. Reason for recall: Failed Dissolution Specifications The recall status is terminated (terminated February 16, 2017). Affected quantity: 8,062 units.
Recall Details
- Product Type
- Drugs
- Report Date
- August 3, 2016
- Initiation Date
- July 11, 2016
- Termination Date
- February 16, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,062 units
Product Description
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
Reason for Recall
Failed Dissolution Specifications
Distribution Pattern
Nationwide
Code Information
Lot #: 3803J141, Exp. 7/2016