Pfizer’s Hospira Recalls Two Lots of Opioid Overdose Antidote Naloxone

Hospira, a Pfizer company, is voluntarily recalling two lots of naloxone hydrochloride injection, an opioid antagonist, to the hospital/institution level due to the potential presence of embedded and loose particulate matter on the syringe plunger.

The company issued a recall notice on June 4, 2018, which was posted on the US Food and Drug Administration website. As of the June 4, 2018 recall notice, Hospira said it had not received reports of any adverse events associated with this issue for the two lots.

The company said in the recall notice that in the event that the impacted product is administered to a patient, the patient has a low likelihood of experiencing adverse events. These adverse events could include: local irritation, allergic reactions, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, pulmonary dysfunction, pulmonary infarction, and toxicity. Hospira says the risk is reduced by the possibility of detection as the labeling contains a clear statement directing visual inspection of the product for particulate matter and discoloration prior to administration. Source: FDA

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