AuroMedics Recalls Linezolid Injection Bags Due to Mold Contamination
AuroMedics Pharma LLC is recalling 9,050 bags of Linezolid Injection 600 mg/300 mL because white particulate matter identified as mold was found in one bag.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
AuroMedics Pharma LLC is recalling 9,050 bags of Linezolid Injection 600 mg/300 mL (2 mg/mL), 300 mL Single-use, ready-to-use flexible plastic infusion bags. The product is identified by Lot # CLZ160007 and has an expiration date of August 2018. The NDC for the product is 55150-242-51.
The recall was initiated because white particulate matter, identified as mold, was found in one bag. The product was distributed throughout the United States.
Healthcare providers and patients should stop using the affected product and contact AuroMedics Pharma LLC for further instructions or a replacement.
The recalled product
- Product
- LINEZOLID (LINEZOLID)
- Brand
- LINEZOLID
- Manufacturer
- AuroMedics Pharma LLC
- Category
- Drug — Antibiotic Injection
- Affected units
- 9,050
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 (2)
- Lot # CLZ160007
- Exp August 2018
Distribution
Distribution scope not specified by the agency.
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