FDA recalls Ofloxacin Otic Solution due to temperature abuse during distribution
Mckesson Medical-Surgical is recalling Ofloxacin Otic Solution nationwide due to exposure to improper storage temperatures that violated manufacturing standards.
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: FDA Class II manufacturing defect (temperature abuse of pharmaceutical). No illnesses or injuries reported, but the defect could affect product stability and integrity, qualifying it as a risk-of-harm product.
Plain-English summary
Mckesson Medical-Surgical Inc. is recalling Ofloxacin Otic Solution 0.3%, 5 mL bottles (NDC 69238-1615-3) distributed nationwide. The product is a prescription antibiotic ear drop manufactured by Amneal/Akyma Pharmaceuticals.
The recall is being issued because the product was exposed to temperature conditions that violated Current Good Manufacturing Practice (cGMP) standards. Temperature abuse during storage or distribution can affect the stability and integrity of pharmaceutical products.
The recall affects all customers who received Ofloxacin Otic Solution from Mckesson Medical-Surgical. Mckesson was unable to identify specific lot numbers by recipient, so customers should refer to distribution dates provided in individual recall notifications.
Patients and healthcare providers should discontinue use of recalled product and contact their pharmacist or healthcare provider regarding replacement medication. No illnesses or injuries have been reported to date.
The recalled product
- Product
- OFLOXACIN (OFLOXACIN OTIC)
- Brand
- OFLOXACIN
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Prescription Antibiotic
- 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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