June 14, 2018
Noting the potential for embedded and loose particulate matter on syringe plungers, Hospira Inc. is voluntarily recalling 2 lots of naloxone hydrochloride injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject single-use cartridge syringe systems, according to the June 13, 2018, US Food and Drug Administration (FDA) Enforcement Report.
“In the event that impacted product is administered to a patient, the patient has a low likelihood of experiencing adverse events ranging from local irritation, allergic reactions, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, pulmonary dysfunction, pulmonary infarction, and toxicity,” Hospira announced in a June 4, 2018, press release. “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.”
The recall affects 164,860 syringes packaged in 2 ways:
- single-unit syringes (NDC 0409-1782-03) from lot 72680LL (Exp. 12/1/18), and
- 10-count boxes (NDC 0409-1782-69) from lot 76510LL (Exp. 4/1/19).
The affected syringes were distributed throughout the United States and in Puerto Rico and Guam.
Hospira initiated the recall June 4, 2018. At press time, the FDA had not yet issued a classification for the recall.
Available with a prescription, naloxone hydrochloride injection is indicated for the complete or partial reversal of opioid depression.
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