Altaire Recalls TRP Stye Relief Due to Sterility Assurance Concerns
Altaire Pharmaceuticals is recalling TRP Stye Relief ophthalmic ointment because the product lacks assurance of sterility. Consumers should stop using the product and contact their healthcare provider.
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. The hazard involves a lack of assurance of sterility in an ophthalmic product, which poses a significant risk of serious injury (such as infection) if the product is non-sterile, fitting the 'Severe' criteria for significant injury risk or Class II with potential for hospitalization.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling TRP Stye Relief, 4 g (NDC 17312-014-13) due to a lack of assurance of sterility. The recall involves 318,412 units distributed nationwide in the United States. The product is an ophthalmic ointment intended for the relief of styes.
The recall was initiated because the manufacturer could not guarantee that the product remained sterile. Sterility is a critical quality attribute for ophthalmic products, as non-sterile eye medications can introduce pathogens to the eye. The source text does not specify the exact cause of the sterility failure or report any specific illnesses or injuries associated with the use of this product.
Consumers who have purchased TRP Stye Relief should stop using the product immediately. They should contact their healthcare provider for guidance on alternative treatments and to determine if any further medical evaluation is necessary. The product should be returned to the point of purchase or disposed of according to local regulations.
The recalled product
- Product
- TRP Stye Relief, 4 g, NDC 17312-014-13
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic
- Affected units
- 318,412
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)
- RHP 8/19 RLD 12/19 SDE 4/20 SID 9/20
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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