Altaire Recalls Ofloxacin Ophthalmic Solution Due to Sterility Concerns
Altaire Pharmaceuticals is recalling Ofloxacin Ophthalmic Solution, 0.3%, due to a lack of assurance of sterility. The recall affects 102,939 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. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in ophthalmic products) are mapped to a score of 4 (Severe), as they are not Class I but involve significant risk.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling Ofloxacin Ophthalmic Solution, USP, 0.3%, 5 mL, NDC 59390-140-05. The recall is being conducted due to a lack of assurance of sterility. The affected product is a prescription-only ophthalmic solution.
The recall involves 102,939 units distributed nationwide in the United States. The source text lists the following lot codes and expiration dates: 17244 8/19, 18057 3/20, and 518307 12/20.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist 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
- OFLOXACIN OPHTHALMIC (OFLOXACIN)
- Brand
- OFLOXACIN OPHTHALMIC
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 102,939
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)
- 17244 8/19 18057 3/20 518307 12/20
UPCs (1)
- 593901400517
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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