The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0462-2020·Announced 2019-11-27

Altaire Recalls Ortho-K Gel Due to Sterility Assurance Concerns

Altaire Pharmaceuticals is recalling Natural Ophthalmics Ortho-K Thick Comfort Gel 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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly given the risk of infection associated with lack of sterility assurance in ophthalmic products.

Plain-English summary

Altaire Pharmaceuticals, Inc. is recalling Natural Ophthalmics Ortho-K Thick Comfort Gel, 15 mL (NDC 68770-143-15). The recall is being conducted because the company lacks assurance of the product's sterility.

The recall involves 81,969 units distributed nationwide in the United States. The affected product codes are 17210 (expiration 7/19), 17378 (expiration 12/19), and 18175 (expiration 7/20).

Consumers should stop using the product and contact Altaire Pharmaceuticals for further instructions or a refund.

The recalled product

Product
Natural Ophthalmics Ortho-K Thick Comfort Gel, 15 mL, NDC 68770-143-15
Manufacturer
Altaire Pharmaceuticals, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
81,969

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)

  • 17210 7/19 17378 12/19 18175 7/20

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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