The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0358-2020·Announced 2019-11-27

Altaire Recalls Puralube Ophthalmic Ointment Due to Sterility Concerns

Altaire Pharmaceuticals is recalling Puralube Ointment Petrolatum Ophthalmic Ointment because the product may not be sterile.

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 FDA classified this recall as Class II, which corresponds to a 'Severe' severity score under the rubric, as it involves a risk of temporary or medically reversible adverse health consequences.

Plain-English summary

Altaire Pharmaceuticals, Inc. is recalling Puralube Ointment Petrolatum Ophthalmic Ointment, a sterile ocular lubricant, due to a lack of assurance of sterility. The recall involves 195,864 units of the product in 1 g and 3.5 g sizes, manufactured for Perrigo in Minneapolis, MN. The affected lots include RJH, SCC, SGA, SGH, SHH, SLL, and TAC, with expiration dates ranging from October 2019 to January 2022.

The product was 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.

Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance. The recall is being conducted to ensure patient safety by removing products that may not meet sterility standards from the market.

The recalled product

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
Manufacturer
Altaire Pharmaceuticals, Inc.
Category
Drug — Ophthalmic Ointment
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 (13)

  • Lot #: RJH
  • Exp 10/19
  • SCC
  • Exp 3/21
  • SGA
  • Exp 7/21
  • SGH
  • SHH
  • Exp 8/21
  • SLL
  • Exp 12/21
  • TAC
  • Exp 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.

See all 134 products in this recall →

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