FDA recall D-0052-2018

Teva Pharmaceuticals USA · Class III · drug

Product

Methylphenidate Hydrochloride Tablets USP, 20 mg, 100-count bottles, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 0591-5884-01.

Reason for recall

Failed Dissolution Specifications: Low out of specification results for dissolution.

Distribution

Nationwide in the USA and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2017-10-17
Report date: 2017-11-01
Termination date: 2018-04-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: North Wales, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0052-2018