Altaire Ciprofloxacin Ophthalmic Solution Recalled for Sterility Assurance Issues
Altaire Pharmaceuticals is recalling Ciprofloxacin HCL Ophthalmic Solution due to a lack of assurance of sterility. The product was distributed nationwide.
What this means for you
Illness, injury, or structural failure has been reported. 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 are assigned a score of 4 (Severe), particularly when involving sterility assurance issues which carry significant risk.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling Ciprofloxacin HCL Ophthalmic Solution, USP, 0.3%, 10 mL, due to a lack of assurance of sterility. The affected product is identified by NDC 59390-217-10 and lot code 18164 7/20.
A total of 636 units were distributed nationwide in the United States. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for further instructions. Altaire Pharmaceuticals is the recalling firm.
The recalled product
- Product
- CIPROFLOXACIN HCL OPHTHALMIC (CIPROFLOXACIN HYDROCHLORIDE)
- Brand
- CIPROFLOXACIN HCL OPHTHALMIC
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic Solution
- Affected units
- 636
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)
- 18164 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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