The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0357-2020·Announced 2019-11-27

Altaire Recalls Perrigo Sulfacetamide Sodium Ophthalmic Ointment Due to Sterility Concerns

Altaire Pharmaceuticals is recalling Perrigo Sulfacetamide Sodium 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, and the hazard involves a lack of assurance of sterility in an ophthalmic product, which poses a significant risk of serious injury or infection.

Plain-English summary

Altaire Pharmaceuticals, Inc. is recalling Perrigo Sulfacetamide Sodium Ophthalmic Ointment USP, 10% Sterile, Rx only, Net Wt 3.5 g (NDC 0574-4190-35). The recall is being conducted because the product lacks assurance of sterility.

The affected product was distributed nationwide in the United States. The recall involves 41,148 units. The specific lots affected are Lot RJD with an expiration date of 10/19 and Lot SHG with an expiration date of 8/20.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for further instructions.

The recalled product

Product
Perrigo Sulfacetamide Sodium Ophthalmic Ointment USP, 10% Sterile, Rx only, Net Wt 3.5 g, Manufactured For: Perrigo Minneapolis, MN 55427, NDC 0574-4190-35
Manufacturer
Altaire Pharmaceuticals, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
41,148

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 (4)

  • Lot #: RJD
  • Exp 10/19
  • SHG
  • Exp 8/20

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.

See all 134 products in this recall →

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