RecallRadar

FDA Drug recall D-0474-2020

Puralube Ophthalmic Ointment, 3.5 gram, Mfd. for Perrigo, Minneapolis, MN 55427, NDC 0574-4025-20

On 2019-11-27 the FDA classified a Class II recall of Puralube Ophthalmic Ointment, 3.5 gram, Mfd. for Perrigo, Minneapolis, MN 55427, NDC 0574-4025-20 by Altaire Pharmaceuticals, citing lack of Assurance of Sterility.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0474-2020
ClassificationClass II
Statuscompleted
Initiated2019-07-02
Published2019-11-27
Last updated2026-09-13 11:52 UTC
CompanyAltaire Pharmaceuticals
DistributionUS

Product

Puralube Ophthalmic Ointment, 3.5 gram, Mfd. for Perrigo, Minneapolis, MN 55427, NDC 0574-4025-20

Reason

Lack of Assurance of Sterility

Identifiers

code_infoRKM 11/19 SGA 7/20 SIF 9/20 SKE 11/20

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0474-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.