The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0354-2020·Announced 2019-11-27

Altaire Recalls Neo-Polycin HC Ophthalmic Ointment Due to Sterility Concerns

Altaire Pharmaceuticals is recalling specific lots of Neo-Polycin HC ophthalmic ointment because the company cannot guarantee the product is 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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for significant health consequences, such as lack of sterility in ophthalmic products, are categorized as Severe.

Plain-English summary

Altaire Pharmaceuticals, Inc. is recalling 87,922 containers of Perrigo Sterile Neo-Polycin HC Ophthalmic Ointment USP. The product is a prescription ophthalmic ointment containing neomycin, polymixin B sulfates, bacitracin zinc, and hydrocortisone acetate. The recall is being conducted because the manufacturer lacks assurance of the product's sterility.

The affected product is distributed nationwide in the United States. The specific lots involved are identified by the codes SEE, SEG, SIE, and SKD, with expiration dates ranging from May 2020 to November 2020. The product is manufactured for Perrigo in Minneapolis, MN, and carries the NDC 0574-4144-35.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
Perrigo Sterile Neo-Polycin HC (neomycin and polymixin B sulfates, bacitracin zinc and hydrocortisone acetate) Ophthalmic Ointment USP, Net Wt. 3.5 g (1/8 oz), Rx only, Mfd. For Perrigo Minneapolis, MN 55427, NDC 0574-4144-35
Manufacturer
Altaire Pharmaceuticals, Inc.
Category
Drug — Ophthalmic Ointment
Hazard
Affected units
87,922

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 (7)

  • Lot #: SEE
  • SEG
  • Exp 5/20
  • SIE
  • Exp 9/20
  • SKD
  • Exp 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.

See all 134 products in this recall →

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