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Naloxone Injection, Syringe System Recalled

June 6, 2018
Certain lots of opioid overdose product may have particulate matter in plunger

A PPM Brief

Just as the federal government is encouraging physicians to prescribe take-home naloxone to their high-risk opioid therapy patients, the maker of the overdose product has issued a recall of several lots. Hospira, Inc., a Pfizer company, is voluntarily recalling 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), to the hospital/institution level due to the potential presence of embedded and loose particulate matter on the syringe plunger, according to an FDA alert.

If affected product is administered, according to the release, “the patient has a low likelihood” of experiencing any adverse events, which may range from local irritation and allergic reactions to pulmonary infarction and toxicity. The affected naloxone labels already advise users to conduct a visual inspection to look for particulate matter or discoloration before administration, and to date, Hospira, Inc. has not received reports of any adverse events associated with these lots, said the statement.

Intra-nasal naloxone products, primarily prescribed for take-home administration in case of emergency, should not be affected by this recall.

See the full recall details

Last updated on: June 7, 2018
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