FDA recall D-1489-2016

Product

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 25 mg 20 UD Capsules (5 x 4), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton NDC 68084-909-32; Blister NDC 68084-909-33

Reason for recall

Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule

Distribution

Product was distributed in the following states: Nationwide

Key facts

Status

Terminated

Initiation date

2016-08-24

Report date

2016-09-14

Termination date

2017-12-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1489-2016