FDA recall D-190-2013

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.

Reason for recall

Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceeding dissolution specifications. All other test specifications were met.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-02-13

Report date

2013-03-13

Termination date

2014-03-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Elizabeth, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-190-2013