The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0466-2020·Announced 2019-11-27

Altaire Pharmaceuticals Recalls Natural Ophthalmics Cataract Eye Drops for Sterility Concerns

Altaire Pharmaceuticals is recalling Natural Ophthalmics Cataract Eye Drops due to a lack of assurance of sterility. The recall affects 61,830 units 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 rubric, an FDA Class II recall involving a significant hazard such as lack of sterility in an ophthalmic product is categorized as Severe (Score 4), as it may cause temporary or medically reversible adverse health consequences.

Plain-English summary

Altaire Pharmaceuticals, Inc. is recalling Natural Ophthalmics Cataract Eye Drops with Cineraria in 15 mL and 25 mL bottles. The recall is being conducted because of a lack of assurance of sterility. The affected product is identified by NDC 68770-130-15 and includes lot codes 17282 (expiration 9/19) and 18121 (expiration 5/20).

A total of 61,830 units were distributed nationwide in the United States. 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, or where the probability of serious adverse health consequences is remote.

Consumers who have this product should stop using it and contact Altaire Pharmaceuticals for instructions on how to return the product or obtain a refund.

The recalled product

Product
Natural Ophthalmics Cataract Eye Drops with Cineraria, 15 mL, 25 mL, NDC 68770-130-15
Manufacturer
Altaire Pharmaceuticals, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
61,830

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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