The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0353-2020·Announced 2019-11-27

Altaire Recalls Neo-Polycin Ophthalmic Ointment Due to Sterility Concerns

Altaire Pharmaceuticals is recalling Neo-Polycin ophthalmic ointment due to a lack of assurance of sterility. The recall covers 121,572 containers 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 FDA classified this recall as Class II. According to the severity rubric, an FDA Class II recall involving a structural or sterility defect in a medical product is categorized as Severe (Score 4).

Plain-English summary

Altaire Pharmaceuticals, Inc. is recalling 121,572 containers of Perrigo Neo-Polycin neomycin and polymixin B sulfates and bacitracin zinc Ophthalmic Ointment, Net Wt. 3.5 g. The product is prescription-only and was manufactured for Perrigo in Minneapolis, MN. The recall is being conducted due to a lack of assurance of sterility.

The affected product is identified by NDC 0574-4250-35. The recall includes two specific lots: Lot SAC with an expiration date of 1/20, and Lot SLK with an expiration date of 12/20. The product was distributed nationwide in the United States.

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

The recalled product

Product
Perrigo Neo-Polycin neomycin and polymixin B sulfates and bacitracin zinc Ophthalmic Ointment Net Wt. 3.5 g, Rx only, Manufactured for Perrigo Minneapolis, MN 55427 NDC 0574-4250-35
Manufacturer
Altaire Pharmaceuticals, Inc.
Category
Drug — Ophthalmic Ointment
Hazard
Affected units
121,572

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 #: SAC
  • Exp 1/20
  • SLK
  • Exp 12/20

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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