Puralube Ophthalmic Ointment Recalled Due to Lack of Sterility Assurance
Altaire Pharmaceuticals is recalling Puralube Ophthalmic Ointment because the product lacks assurance of sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score per the rubric, particularly given the risk of infection from non-sterile ophthalmic products.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling Puralube Ophthalmic Ointment, 3.5 gram, manufactured for Perrigo. The recall involves 195,864 units distributed nationwide in the United States. The specific reason for the recall is a lack of assurance of sterility.
The affected product is identified by NDC 0574-4025-20. The source text lists the following codes: RKM 11/19, SGA 7/20, SIF 9/20, and SKE 11/20. The product was manufactured for Perrigo in Minneapolis, MN.
Consumers should stop using the product and contact their healthcare provider or pharmacist for guidance. The source text does not specify additional consumer instructions or report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Puralube Ophthalmic Ointment, 3.5 gram, Mfd. for Perrigo, Minneapolis, MN 55427, NDC 0574-4025-20
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 195,864
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- RKM 11/19 SGA 7/20 SIF 9/20 SKE 11/20
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 134 recalled by Altaire Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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