FDA recall D-0356-2020

Altaire Pharmaceuticals, Inc. · Class II · drug

Product

Perrigo Bacitracin Ophthalmic Ointment, Net Wt. 3.5 g (1/8 oz), Rx only, Manufactured For: Perrigo Minneapolis, MN 55427, NDC 0574-4022-35

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-0356-2020