Opioid overdose antidote recalled over particulate matter

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The FDA announced a recall of Naloxone on Monday after the antidote’s manufacturer flagged a potential issue with the syringe plunger. Hospira Inc., which is a Pfizer company, said the potential presence of embedded and loos particulate matter could cause a patient to experience adverse effects such as irritation, allergic reactions, pulmonary dysfunction or others.

The two lots, 72680LL and 76510LL of Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject Single-use cartridge syringe system (NDC 0409-1782-69), was distrubted nationwide from February 2017 to February 2018.

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The company said that it had not received any complaints in relation to the recall.

“Hospira, Inc., places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process,” the company said, according to a news release on the FDA website. “Hospira, Inc., has notified wholesalers/distributors/hospitals to arrange for return of any recalled product.”