FDA recall D-0358-2020

Altaire Pharmaceuticals, Inc. · Class II · drug

Product

Puralube Ointment Petrolatum Ophthalmic Ointment, Sterile Ocular Lubricant, Net Wt. 1 g (NDC 0574-4025-11) and Net Wt. 3.5 g (1/8 oz.) (NDC 0574-4025-35), Manufactured for Perrigo, Minneapolis, MN 55427

Reason for recall

Lack of Assurance of Sterility

Distribution

U.S.A. Nationwide

Key facts

Status: Completed
Initiation date: 2019-07-02
Report date: 2019-11-27
Voluntary/Mandated: Voluntary: Firm initiated
Location: Aquebogue, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0358-2020