The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0467-2020·Announced 2019-11-27

Altaire Recalls Natural Ophthalmics Eye Drops Due to Sterility Concerns

Altaire Pharmaceuticals is recalling Natural Ophthalmics Allergy Desensitization Eye Drops because the company cannot ensure 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, which indicates a situation that may cause temporary or medically reversible adverse health consequences. The hazard of non-sterile eye drops is significant, warranting a 'Severe' rating under the rubric for FDA Class II recalls.

Plain-English summary

Altaire Pharmaceuticals, Inc. is recalling Natural Ophthalmics Allergy Desensitization Eye Drops, 15 mL (NDC 68770-120-15). The recall involves 20,666 units distributed nationwide in the United States. The specific lot codes affected are 17282 (expiration date 9/19) and 18121 (expiration date 5/20).

The recall was initiated due to a lack of assurance of sterility. This means the manufacturer cannot guarantee that the eye drops are free from microbial contamination, which poses a risk to patients using the product.

Consumers who have these specific lot numbers should stop using the product and contact their healthcare provider or the recalling firm for instructions on how to return the product or obtain a replacement.

The recalled product

Product
Natural Ophthalmics Allergy Desensitization Eye Drops, 15 mL, NDC 68770-120-15
Manufacturer
Altaire Pharmaceuticals, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
20,666

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 (1)

  • 17282 9/19 18121 5/20

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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