Saturday, 23 June, 2018

Naloxone Recalled Due To Syringe Plunger Particulate

FDA recalls Naloxone distributed nationwide Opioid overdose antidote recalled over particulate matter
Anna Jefferson | 07 June, 2018, 19:42

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

Drugmaker Hospira issued a nationwide recall for two lots of its injectable opioid overdose antidote Naloxone over the potential presence of embedded and loose particulate matter on the syringe plunger.

According to the company, the risk of developing adverse events is low, and that risk is reduced because the product's label directs users to visually inspect the product prior to administration.

The product, a syringe injection, was distributed to hospitals and institutions across the U.S., Puerto Rico and Guam between February 2017 to February 2018.

As per the FDA, those who administer the Naloxone drug should check it for any particulate matter or discoloration before injecting it to a person. Adverse reactions may include local irritation, allergic reactions, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, pulmonary dysfunction, pulmonary infarction, and toxicity.

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Naloxone, also known by the brand name Narcan, can reverse an opiate overdose, but it can wear off and victims must get medical attention afterward. "Hospira, Inc., has notified wholesalers/distributors/hospitals to arrange for return of any recalled product".

When administered, Naloxone can quickly restore normal respiration to someone whose breathing has slowed or stopped due to opioids. In the press release put out by the Food and Drug Administration, Hospira says that it is recalling lots 72680LL and 76510LL of Naloxone.

Naloxone Hydrochloride is sold for IV use, intramuscular use and subcutaneous use.

78 people die each day from opioid overdoses.

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