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.
What this means for you
Illness, injury, or structural failure has been reported. 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.
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