The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0356-2020·Announced 2019-11-27

Altaire Recalls Perrigo Bacitracin Ophthalmic Ointment Due to Sterility Concerns

Altaire Pharmaceuticals is recalling Perrigo Bacitracin Ophthalmic Ointment because the product lacks assurance of sterility. The recall covers 651,528 units distributed nationwide.

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. According to the rubric, an FDA Class II recall involving a structural defect or significant risk (lack of sterility in an ophthalmic product) is categorized as Severe (Score 4), as it may cause temporary or medically reversible adverse health consequences.

Plain-English summary

Altaire Pharmaceuticals, Inc. is recalling Perrigo Bacitracin Ophthalmic Ointment, Net Wt. 3.5 g (1/8 oz), NDC 0574-4022-35. The recall is being conducted because the product lacks assurance of sterility. The affected product is a prescription-only ophthalmic ointment manufactured for Perrigo Minneapolis, MN.

The recall involves 651,528 units that were distributed nationwide in the United States. The source text lists specific lot numbers and expiration dates for the affected units, including lots RGA, RGE, RGG, RGH, RHM, RJB, RJA, SCA, SIC, TAP, and TDE.

Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for further instructions. The recall is classified as FDA Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Perrigo Bacitracin Ophthalmic Ointment, Net Wt. 3.5 g (1/8 oz), Rx only, Manufactured For: Perrigo Minneapolis, MN 55427, NDC 0574-4022-35
Manufacturer
Altaire Pharmaceuticals, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
651,528

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 (11)

  • Lot #: RGA 7/19 7/31/2017
  • RGE 7/19 8/11/2017
  • RGG7/19 8/11/2017
  • RGH 7/19 8/17/2017
  • RHM 8/19 9/14/2017
  • RJB 10/19 10/23/2017
  • RJA 10/19 10/23/2017
  • SCA 3/20 3/22/2018
  • SIC 9/20 10/9/2018
  • TAP 1/21 2/26/2019
  • TDE 4/21 5/30/2019

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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