Altaire Recalls Homatropine Hydrobromide Ophthalmic Solution Due to Sterility Concerns
Altaire Pharmaceuticals is recalling Homatropine Hydrobromide Ophthalmic Solution 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 source text identifies the agency classification as Class II. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential for adverse health consequences such as sterility failures in ophthalmic products.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling Homatropine Hydrobromide Ophthalmic Solution, USP, 5%, 5 mL, sterile, prescription only. The recall is being conducted because the company lacks assurance of the product's sterility.
The affected product is identified by NDC 59390-192-05. The recall involves 23,974 units distributed nationwide in the United States. Specific lot codes associated with the recall are 17041 (expiration 2/20), 17186 (expiration 6/20), and 18068 (expiration 3/21).
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for guidance. 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.
The recalled product
- Product
- HOMATROPINE HYDROBROMIDE OPHTHALMIC (HOMATROPINE HYDROBROMIDE)
- Brand
- HOMATROPINE HYDROBROMIDE OPHTHALMIC
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic Solution
- Hazard
- Affected units
- 23,974
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)
- 17041 2/20 17186 6/20 18068 3/21
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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