Drug Safety Alerts

Linezolid Injection Class I Recall

2/14/18

On February 14, 2018, the United States Food and Drug Administration (FDA) issued a notice regarding a Class I recall of linezolid injection 600 mg/300 mL (2 mg/mL) 300 mL (NDC # 55150-0242-51). This recall was issued because of the presence of white particulate matter identified as mold was found in one bag. Use of a non-sterile injectable product could result in fatal infections in a broad array of patients.
This recall affects lot number CLZ160007 exp. 08/31/2018. No other lots are affected by this issue.

To date, AuroMedics Pharma LLC has not received reports of any adverse events or identifiable safety concerns attributed to this recall.

This recall was originally issued on December 22, 2017 to the retail-level. The FDA classified this as a Class I Recall on February 14, 2018.

Linezolid injection is an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia (1.1); Community-acquired pneumonia (1.1); Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis (1.2); Uncomplicated skin and skin structure infections (1.2); Vancomycin-resistant Enterococcus faecium infections (1.3). Linezolid injection is supplied as a ready-to-use sterile, clear colorless to slightly yellow color isotonic solution for intravenous infusion. Each 300 mL contains 600 mg of linezolid. Inactive ingredients are sodium citrate, citric acid, and dextrose in an aqueous vehicle for intravenous administration. The sodium (Na+) content is 0.38 mg/mL (5 mEq/300 mL bag). It is available in single-use, ready-to-use flexible plastic infusion bags in a foil laminate overwrap. The infusion bags and ports are latex-free.

The product can be identified as a single-use, ready-to-use flexible plastic infusion bag in a foil laminate overwrap. Auromedics commenced shipping the product to customers May 15 through August 14, 2017 and was distributed to wholesalers and/or hospitals nationwide.

AuroMedics Pharma LLC is notifying its distributors and customers by recall letters and is arranging for return/replacement etc. of all recalled product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program.

CVS Caremark Response: This product is not carried by the CVS Caremark Mail Service Pharmacies.

For more information about this recall, health care providers may contact Aurobindo Customer Service at 1-866-850-2876, Monday through Friday, 9:00 am to 5:00 pm (ET) and select option 1. You may also contact the FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit https://www.accessdata.fda.gov.