Ciprofloxacin eye drops recalled due to manufacturing temperature deviations
McKesson is recalling Ciprofloxacin Ophthalmic Solution 0.3% nationwide due to temperature deviations during manufacturing. The FDA classifies this as a Class II recall.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall of a prescription medication with manufacturing deviations. While no illnesses or injuries have been reported, Class II recalls indicate potential for adverse health consequences. The actual harm remains theoretical without reported incidents.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Ciprofloxacin Ophthalmic Solution 0.3% distributed nationwide due to current Good Manufacturing Practice (cGMP) deviations involving temperature abuse during the manufacturing process.
The affected product is a 10 mL bottle of Ciprofloxacin Ophthalmic Solution 0.3%, a prescription antibiotic eye medication manufactured by Alcon Laboratories, Inc. (NDC 61314-0656-10). The product was distributed nationwide through McKesson Medical-Surgical.
The FDA has classified this as a Class II recall. McKesson is unable to identify specific lot numbers affected, but customers have been provided with distribution dates relevant to their shipments.
Patients who may have received this medication should consult with their pharmacy or prescriber to determine if their product is affected and whether a replacement prescription is needed.
The recalled product
- Product
- Ciprofloxacin Ophthalmic Solution 0.3%, 10 mL bottle, Rx only, Manufactured by: Alcon Laboratories, Inc., NDC 61314-0656-10
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 1
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 130 recalled by Mckesson Medical-Surgical Inc. Corporate Office 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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