Altaire Recalls TRP Pink Eye Relief Due to Sterility Concerns
Altaire Pharmaceuticals is recalling TRP Pink Eye Relief eye drops because the company cannot guarantee 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, and the hazard involves a lack of sterility assurance for an ophthalmic product, which poses a significant risk of serious injury or infection.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling TRP Pink Eye Relief, 10 mL (NDC 17312-013-15). The recall was initiated because the manufacturer lacks assurance of the product's sterility.
The affected product was distributed nationwide in the United States. The recall covers 1,381,638 units. Specific lot codes and expiration dates are listed in the official recall notice.
Consumers should stop using the product and contact their healthcare provider or the manufacturer for instructions on how to return or dispose of the medication.
The recalled product
- Product
- TRP Pink Eye Relief, 10 mL, NDC 17312-013-15
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic
- Affected units
- 1,381,638
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)
- 17185 6/20 17228 7/20 17349 11/20 18073 3/21 18218 8/21 18303 12/21
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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