Morphine Lot Recalled Due to Excessive Injection Volume

Emma Hitt, PhD

Disclosures

April 19, 2012

April 19, 2012 — Hospira Inc has initiated a voluntary recall of morphine sulfate injections because of a customer report of 2 Carpuject syringes containing more than the 1 mL labeled fill volume.

The company announcement was made yesterday as part of the MedWatch FDA Safety Information and Adverse Event Reporting Program.

The product is a prefilled glass cartridge intended for use with the Carpuject Syringe system. The affected lot number is 10830LL; contains Morphine Sulfate Injection USP, 4 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject, NDC 0409-1258-30; and was distributed in January 2012. The expiration date is April 1, 2013.

A total of 212,000 units are contained in the lot, according to company spokesperson Dan Rosenberg.

Morphine Sulfate Carpuject syringes 4 mg/mL are packaged in Slim-Pak tamper detection packages, with each box containing 10 Carpuject syringes (NDC 0409-1258-30).

The product was initially distributed to wholesalers and a limited number of hospitals in Arizona, Colorado, Hawaii, Illinois, Indiana, Michigan, Minnesota, Ohio, Texas, and Virginia.

The company has not received any related reports of adverse events, and the company considered it to be an "isolated event."

The company "has initiated an investigation to determine the root cause and preventive actions," they write in their announcement on the FDA Web site. Affected inventory should be returned by calling Stericycle at 1-888-912-7088. Replacement product can be obtained by mailing form DEA 222 to Hospira 1635 Stone Ridge Drive, Stone Mountain, Georgia 30083.

The manufacturer emphasizes that opioid pain medications such as morphine have life-threatening consequences if overdosed; consequences can include respiratory depression and low blood pressure.

To report adverse events related to this product, contact MedWatch by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.

Comments

3090D553-9492-4563-8681-AD288FA52ACE
Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.
Post as:

processing....