The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0464-2020·Announced 2019-11-27

Altaire Recalls Ortho-K Eye Drops Due to Sterility Concerns

Altaire Pharmaceuticals is recalling Natural Ophthalmics Ortho-K Thin 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 corresponds to a Severe severity score under the rubric for drug recalls involving potential serious health consequences.

Plain-English summary

Altaire Pharmaceuticals, Inc. is recalling 84,216 units of Natural Ophthalmics Ortho-K Thin Eye Drops, 15 mL (NDC 68770-144-15). The recall was initiated because the manufacturer lacks assurance that the product is sterile.

The affected units were distributed nationwide in the United States. The recall includes products with the following lot codes and expiration dates: 17375 (12/19), 17376 (12/19), 18190 (7/20), and 18191 (8/20).

Consumers should stop using the product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Natural Ophthalmics Ortho-K Thin Eye Drops, 15 mL, NDC 68770-144-15
Manufacturer
Altaire Pharmaceuticals, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
84,216

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)

  • 17375 12/19 17376 12/19 18190 7/20 18191 8/20

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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