FDA recall D-842-2013

Teva Pharmaceuticals USA, Inc. · Class II · drug

Product

Terazosin Hydrochloride Capsules,10 mg, 100-count bottle, Rx only, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-4339-01

Reason for recall

Labeling -label error on declared strength: unopened, sealed bottle of Terazosin Hydrochloride (HCl) 10mg Capsules contained Terazosin HCl 5 mg Capsules

Distribution

Nationwide and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2013-07-23
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-842-2013