FDA recall D-0566-2016

Product

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets (Mixed Salts of a Single Entity Amphetamine Product), 10 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0972-02, UPC 3 0555-0972-02 0.

Reason for recall

Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-11-12

Report date

2016-01-20

Termination date

2016-11-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Wales, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0566-2016