FDA recall D-0395-2015

Product

Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg, 90-count bottles, Rx Only, Manufactured by: Actavis Elizabeth LLC, Elizabeth, NJ 07201 USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA; NDC 45963-305-09, UPC 3 45963-305-09 1.

Reason for recall

Failed Dissolution Specifications

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-02-10

Report date

2015-03-11

Termination date

2015-08-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Elizabeth, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0395-2015