FDA recall D-1482-2016

Product

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 10 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton NDC 68084-936-25; Blister NDC 68084-936-95

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-1482-2016