PlainRecalls
FDA Drug Moderate Class II Completed

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

Reported: November 27, 2019 Initiated: July 2, 2019 #D-0358-2020

Product Description

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

Details

Units Affected
195,864 unts
Distribution
U.S.A. Nationwide
Location
Aquebogue, NY

Frequently Asked Questions

What product was recalled?
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. Recalled by Altaire Pharmaceuticals, Inc.. Units affected: 195,864 unts.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on November 27, 2019. Severity: Moderate. Recall number: D-0358-2020.