Hydromorphone Hydrochloride Injection 2 MG/ML, 1 mL fill in 2.5 mL Carpuject by Hospira, Inc Recalled as it May Contain More Than Intended Fill Volume causing Life-Threatening Consequences

Risk Managers and Pharmacists are informed by the US FDA that Hospira, Inc., Hydromorphone Hydrochloride Injection 2 MG/ML, 1 mL fill in 2.5 mL Carpuject is recalled because it may contain more than the intended fill volume resulting in respiratory depression and reduced heart rate including circulatory collapse.

Background of Hydromorphone Hydrochloride 2 MG/ML, 1 mL fill in 2.5 mL Carpuject

Hydromorphone Hydrochloride Injection 2 MG/ML, 1 mL fill in 2.5 mL Carpuject, by Hospira Inc, is a prefilled glass cartridge to be used with the Carpuject Syringe system.  The Carpuject syringe system consists of pre-filled cartridges that are loaded into a syringe holder to create a drug delivery system. FDA Alert on Hydromorphone Hydrochloride Injection 2 MG/ML, 1 mL fill in 2.5 mL Carpuject

FDA’s reason for the recall is that Hydromorphone Hydrochloride Injection 2 MG/ML, 1 mL fill in 2.5 mL Carpuject, may contain more than the intended fill volume. In case of opioid pain medications such as Hydromorphone the consequences can be life-threatening including respiratory depression, low blood pressure and reduced heart rate including circulatory collapse.

The lot that is affected by this recall is 12720LL. This lot has an expiration date of December 1, 2013. It was distributed in March – May 2012.

FDA Recommendation on Hydromorphone Hydrochloride 2 MG/ML, 1 mL fill in 2.5 mL Carpuject

“Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-866-873-0312 to arrange for the return of the product. Replacement product from other lots is available. Customers can send their DEA 222 form to Hospira, 1635 Stone Ridge Drive, Stone Mountain, GA 30083 to order replacement product.

For medical inquiries, please contact Hospira Medical Communications at 1-800-615-0187. This phone number is available 24 hours a day, seven days a week.”

Contacting the FDA to report cases with Hydromorphone Hydrochloride Injection 2 MG/ML, 1 mL fill in 2.5 mL Carpuject

In case of detection of adverse events or side effects related to the use of Hydromorphone Hydrochloride Injection 2 MG/ML, 1 mL fill in 2.5 mL Carpuject, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted Online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to:  1-800-FDA-0178

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