D-0395-2015 Class II Terminated
FDA drug recall D-0395-2015 was initiated by Actavis Elizabeth LLC on February 10, 2015 and is designated Class II. Reason for recall: Failed Dissolution Specifications The recall status is terminated (terminated August 14, 2015). Affected quantity: 42 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- March 11, 2015
- Initiation Date
- February 10, 2015
- Termination Date
- August 14, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 42 bottles
Product Description
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.
Reason for Recall
Failed Dissolution Specifications
Distribution Pattern
Nationwide
Code Information
Lot #: 2020E141, Exp 07/15