Carpuject Hydromorphone Prefilled Syringes Recalled

Emma Hitt, PhD

Disclosures

August 16, 2012

August 16, 2012 — A voluntary user level recall of one lot of hydromorphone injection, USP, 2 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject, NDC 0409-1312-30, manufactured by Hospira, has been issued by the US Food and Drug Administration (FDA) and the company because of a reported complaint of a single unit containing more than the 1 mL labeled fill volume.

The recall comes after an FDA advisory warning issued on May 23 that urged healthcare providers to visually inspect about 46 million units of Hospira Carpuject prefilled cartridges for overfill. Included in that advisory were prefilled syringes containing several drugs, one of which was hydromorphone.

In addition, on April 19, a voluntary recall of morphine sulfate injection was issued by Hospira, also because it contained more than 1 mL of labeled fill volume.

According to the safety communication sent this week by MedWatch, the FDA's safety information and adverse event reporting program, the hydromorphone injection recall applies to lot number 12720LL. The expiration date is December 1, 2013, and the lot was distributed between March and May of this year.

"Hospira had notified healthcare professionals in May 2012 regarding the potential for overfill in the prefilled Carpuject syringe system, as some syringes may contain more medication than is stated on the label," the manufacturer press release states.

"This specific lot was identified in that communication and was manufactured prior to the implementation of those preventive actions," they note. "Hospira is undertaking this recall in consideration of the potential for safety issues if the product is administered to patients."

To date, no reports of adverse events have been issued for this lot, the manufacturer states.

Any affected product should be quarantined and returned by calling Stericycle at 1-866-873-0312.

Healthcare professionals and patients are encouraged to report overfilled Carpuject prefilled cartridges to MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

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