FDA recall D-849-2013

Teva Pharmaceuticals USA, Inc. · Class II · drug

Product

Methylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5348-01

Reason for recall

Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2013-06-18
Report date: 2013-08-14
Termination date: 2014-08-27
Voluntary/Mandated: Voluntary: Firm initiated
Location: Sellersville, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-849-2013