The Recall Desk
HighFDA (Drugs)·D-1114-2022·Announced 2022-06-15

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.

What this means for you

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
Hazard
  • temperature-abuse
  • manufacturing-defect

Distribution

Distributed nationwide across the United States.

Related recalls

Same category