Actavis Elizabeth LLC recalls Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended
Recalled March 13, 2013 · FDA recall D-190-2013 · Actavis Elizabeth
Hazard
Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceeding dissolution specifications. All other test specifications were met. · FDA Class III
Units
9,264 Bottles
Sold at
Nationwide
Description
Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceeding dissolution specifications. All other test specifications were met.
Product
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-Release Capsules, 15 mg, Rx Only, C II, 100 capsules per bottle, MFG. By Actavis Elizabeth LLC. 200 Elmora Ave, Elizabeth, NJ, 07207, USA, NDC 0228-3063-11.
Manufacturer(s)
Actavis Elizabeth LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →