Altaire Recalls Puralube Petrolatum Ophthalmic Ointment Due to Sterility Concerns
Altaire Pharmaceuticals is recalling Puralube Petrolatum Ophthalmic Ointment because the company cannot ensure the product is sterile. Consumers should stop using the product and contact their healthcare provider.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II. According to the rubric, an FDA Class II recall involving a structural defect or significant risk (lack of sterility in an ophthalmic product) aligns with a 'Severe' rating, particularly given the potential for serious adverse health consequences in a sterile-sensitive area like the eye, even if specific hospitalizations are not explicitly detailed in the provided snippet.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling Puralube Petrolatum Ophthalmic Ointment, Net Wt 3.5 gram (1/8 oz), manufactured for Perrigo. The recall was initiated because the company lacks assurance of the product's sterility. The affected product is identified by NDC 0574-4025-35 and includes specific lot codes: RJH 10/19, SCC 3/21, SGA 7/21, SGH 7/21, SHH 8/21, SLL 12/21, and TAC 1/22.
The recall covers 273,100 units distributed nationwide in the United States. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Consumers who have this product should stop using it immediately. They should contact their healthcare provider for guidance on alternative treatments and to report any potential adverse effects. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Puralube Petrolatum Ophthalmic Ointment, Net Wt 3.5 gram (1/8 oz), Mfd. for Perrigo, Minneapolis, MN 55427, NDC 0574-4025-35
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic Ointment
- Affected units
- 273,100
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)
- RJH 10/19 SCC 3/21 SGA 7/21 SGH 7/21 SHH 8/21 SLL 12/21 TAC 1/22
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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