Altaire Recalls Ciprofloxacin Ophthalmic Solution Due to Sterility Concerns
Altaire Pharmaceuticals is recalling Ciprofloxacin HCl Ophthalmic Solution because the company cannot ensure 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 carries a significant risk of serious injury or infection.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling Ciprofloxacin HCl Ophthalmic Solution, 0.3%, 5 mL, NDC 59390-217-05. The recall involves 6,024 units of the product, specifically Lot #18164 with an expiration date of 7/20. The product was distributed nationwide in the United States.
The recall was initiated due to a lack of assurance of sterility. This means the manufacturer cannot guarantee that the ophthalmic solution is free from microbial contamination, which poses a risk to patients using the eye drops.
Consumers who have this specific lot of Ciprofloxacin HCl Ophthalmic Solution should stop using it immediately. They should contact their healthcare provider for further instructions and return the product to the pharmacy or point of purchase for a refund or replacement.
The recalled product
- Product
- CIPROFLOXACIN HCL OPHTHALMIC (CIPROFLOXACIN HYDROCHLORIDE)
- Brand
- CIPROFLOXACIN HCL OPHTHALMIC
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic Solution
- Affected units
- 6,024
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 (2)
- Lot #: 18164
- Exp 7/20
UPCs (1)
- 4776638217054
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.
See all 134 products in this recall →Related recalls
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