FDA Drug recall D-0358-2020
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…
- FDA Drug
- Class II
- completed
- Published 2019-11-27
On 2019-11-27 the FDA classified a Class II recall of 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… by Altaire Pharmaceuticals, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0358-2020 |
| Classification | Class II |
| Status | completed |
| Initiated | 2019-07-02 |
| Published | 2019-11-27 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Altaire Pharmaceuticals |
| Distribution | US |
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
Lack of Assurance of Sterility
Identifiers
| code_info | Lot #: RJH, Exp 10/19; SCC, Exp 3/21; SGA, Exp 7/21; SGH, Exp 7/21; SHH, Exp 8/21; SLL, Exp 12/21; TAC, Exp 1/22 |
|---|
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-0358-2020%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.