FDA recall D-1283-2015

Product

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, (CII), 10 mg (Mixed Salts of a Single Entity Amphetamine Product), 100 count bottles, manufactured at Barr Laboratories, Inc. Forest, VA for Teva Pharmaceuticals USA, Sellersville, PA --- NDC 0555-0972-02

Reason for recall

Failed Impurities/Degradation Specifications: out of specification for unknown impurity

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-06-24

Report date

2015-08-12

Termination date

2016-08-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Horsham, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1283-2015