Levofloxacin 500 mg Tablets Recalled Due to Manufacturing Temperature Abuse
Mckesson Medical-Surgical is recalling Levofloxacin 500 mg tablets nationwide due to temperature abuse during manufacturing that violated pharmaceutical quality 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: This is an FDA Class II recall involving cGMP deviations (temperature abuse) affecting pharmaceutical manufacturing. No illnesses or injuries have been reported, and the hazard is potential rather than realized, making this a High severity issue per the rubric for risk-of-harm products without reported injury.
Plain-English summary
Mckesson Medical-Surgical Inc. is recalling Levofloxacin tablets (500 mg, 100-count unit dose boxes) nationwide due to manufacturing deviations involving temperature abuse. The product is distributed across the United States.
The recall stems from temperature abuse during manufacturing that violates current Good Manufacturing Practice (cGMP) standards. Temperature exposure during production can compromise pharmaceutical quality and medication effectiveness.
Affected customers have received recall notification letters containing distribution dates. If you received this medication, contact your pharmacist or healthcare provider with the date you received the product to determine if it is affected.
Consumers with questions should contact Mckesson Medical-Surgical Inc. or consult their pharmacist or healthcare provider.
The recalled product
- Product
- LEVOFLOXACIN (LEVOFLOXACIN)
- Brand
- LEVOFLOXACIN
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Antibiotic
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.
See all 130 products in this recall →Related recalls
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