FDA recall D-0679-2017

Novartis Pharmaceuticals Corp. · Class III · drug

Product

Pilocarpine Hydrochloride Ophthalmic Solution 4% , packaged in 15 mL bottles, Rx Only, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 Sandoz Princeton, NJ 08540, NDC 61314-206-15

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-0679-2017