Maker of Naloxone issues recall due to ‘loose particulate matter’

Grant Boone
June 7, 2018

This recall is only for Naloxone used in syringes, and not the nasal spray.

The FDA announced a recall of Naloxone on Monday after the antidote's manufacturer flagged a potential issue with the syringe plunger.

Package labeling recommends visual inspection to detect the presence of discoloration or particulates before administration, which would diminish the risks for using these lots.

The company says distributors or retailers with an existing inventory of the lots, which are being recalled, should stop use and distribution and quarantine immediately.

Exposure to these particulates could have adverse health effects on users of Naloxone.

Conservative icon David Koch leaving business, politics | AP business
The firm, with annual revenue of $100 billion, operates pipelines and produces fertiliser but also manufactures consumer goods. "Unfortunately, these issues have not been resolved and his health has continued to deteriorate", Charles Koch wrote.

Because of the ongoing drug epidemic, many local first responders have been issued Naloxone, which is also called Narcan, in recent years. People who have experienced adverse effects from the particulate matter should contact the FDA. A representative from the Indiana State Department of Health said none of the naloxone distributed by the department is part of the recall.

Affected products are intended for intravenous (IV) use, intramuscular use and subcutaneous use only, FDA said.

The recall affects single use sterile cartridge units with lot numbers 72680LL and 76510LL in 0.4 mg/ml, 1 mL in, and 2.5 mL strengths.

When administered, Naloxone can quickly restore normal respiration to someone whose breathing has slowed or stopped due to opioids. The data came from the fatal overdose from 31 states that produced reliable reports of drug-related causes of death.

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