Hospira Recalls Hydromorphone HCl Injection

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The company is recalling three lots of Hydromorphone HCl Injection USP CII 10 mg/mL, 1 mL in 2 mL Single Dose Vials because of possibly empty or cracked vials.

Hospira, a Pfizer company, announced on March 5, 2018, that it was voluntarily recalling three lots of Hydromorphone HCl Injection USP CII 10 mg/mL, 1 mL in 2 mL Single Dose Vials to the hospital level. The recall was initiated on Feb. 7, 2018 because some units might have empty or cracked vials. Hydromorphone HCl, an opioid agonist, is used to manage severe pain.

According to the company, cracked vials might lead to a compromise in sterility, which may cause bloodstream infections. In addition to sterility concerns, the cracked vials could result in injury to healthcare professions. As of March 5, Hospira has not received any reports of adverse events associated with the recalled product.

The affected lots have expiration dates of November 1, 2018, September 1, 2018, and October 1, 2018 and were distributed nationwide. The company is advising distributers and hospitals to stop use and distribution of the recalled lots. Adverse events may be reported to FDA’s MedWatch program.


Source: FDA