Altaire Recalls OCuSOFT Homatropine Hydrobromide Ophthalmic Solution Due to Sterility Concerns
Altaire Pharmaceuticals is recalling OCuSOFT Homatropine Hydrobromide Ophthalmic Solution, 5%, due to a lack of assurance of sterility. The recall covers 81,403 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 recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a significant risk such as lack of sterility in an ophthalmic product warrants a score of 4 (Severe), as it may cause temporary or medically reversible adverse health consequences.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling OCuSOFT Homatropine Hydrobromide Ophthalmic Solution, 5%, 5 mL, Rx only. The recall is being conducted because of a lack of assurance of sterility in the product. The affected product is manufactured for Ocusoft, Inc. and identified by NDC 54799-431-05.
The recall involves 81,403 units of the ophthalmic solution. These units were distributed nationwide in the United States. The source text lists specific lot codes and expiration dates associated with the recalled inventory, including codes 17186, 17345, 19010, 17041, and 16217.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions. 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
- OCuSOFT Homatropine Hydrobromide Ophthalmic Solution, 5%, 5 mL, Rx only, Manufactured for Ocusoft, Inc, Rosenberg, TX 77471, Mfd. by Altaire Pharmaceuticals, Inc, Aquebogue, NY 11931 NDC 54799-431-05
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic Solution
- Hazard
- Affected units
- 81,403
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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