Andrea K. Kerrigan, FDA, outlines how validation, data integrity, and QRM determine whether digital tools and AI strengthen or undermine CGMP compliance.
News|Articles|June 4, 2018
Hospira Recalls Naloxone Hydrochloride
Author(s)Pharmaceutical Technology Editors
The company is recalling two lots of Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject Single-use cartridge syringe system due to particulate matter on the syringe plunger.
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On June 4, 2018, Hospira, Inc., a Pfizer company,
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. Adverse reactions may include local irritation, allergic reactions, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, pulmonary dysfunction, pulmonary infarction, and toxicity.
The recalled lots were distributed nationwide to wholesalers, distributors, and hospitals in the United States, Puerto Rico, and Guam from February 2017 to February 2018. As of June 4, no adverse events associated with the recalled product were reported. Adverse events may be reported to FDA via its
Naloxone Hydrochloride, an opioid antagonist, is used to treat opioid depression. It is also indicated for the diagnosis of known or suspected opioid overdosage, and as an adjunctive agent for the management of septic shock. It is available as a sterile solution for intravenous, intramuscular, and subcutaneous administration.
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