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Safety Concerns Trigger Naloxone Hydrochloride Recall

Deborah Brauser
June 05, 2018

Two lots of naloxone hydrochloride injection within the Carpuject single-use cartridge syringe system are being voluntarily recalled by Hospira Inc because embedded or loose particulate matter may be present on the syringe's plunger.

The US Food and Drug Administration (FDA) announced the safety alert on its MedWatch site.

Indications for the opioid antagonist include the complete or partial reversal of opioid depression, for known or suspected opioid overdoses, or as an adjunctive medication for septic shock.

According to the alert, lots #72680LL and #76510LL of naloxone hydrochloride injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL of the cartridge system are being recalled.

Affected lots were distributed between February 2017 and February 2018 in the United States, Guam, and Puerto Rico.

Although adverse events (AEs) stemming from an affected product could include allergic reactions, irritation, pulmonary emboli or infarction, tissue ischemia, and end-organ granuloma, the company, which is a division of Pfizer, reports not receiving any AE-related reports so far.

"Distributors or retailers with an existing inventory of the lots…should stop use and distribution and quarantine immediately," the FDA notes in a statement. "If you have further distributed the recalled product, to the wholesale or retail level, please notify any accounts or additional locations."

Any healthcare professional or patient who experiences an AE related to these products are urged to report the information to the FDA's MedWatch Safety Information and Adverse Event Reporting Program. Clinicians with any questions regarding the recall itself can contact Pfizer directly.

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SOURCE: Medscape, June 05, 2018.

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