FDA recall D-0678-2017

Novartis Pharmaceuticals Corp. · Class III · drug

Product

Isopto Carpine (pilocarpine hydrochloride opthalmic solution) 4%, packaged in 15 mL bottle, Rx only, Manufactured by: Alcon Laboratories, Inc. Fort Worth Texas 76134 USA NDC 0998-0206-15

Reason for recall

Failed Impurities/Degradation Specifications.

Distribution

nationwide

Key facts

Status: Terminated
Initiation date: 2017-03-22
Report date: 2017-05-03
Termination date: 2020-02-05
Voluntary/Mandated: Voluntary: Firm initiated
Location: East Hanover, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0678-2017