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FDA MEDWATCH ALERTS

March 28, 2014

FDA Update on the Shortage of Normal Saline

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FDA Update on the Shortage of Normal Saline

March 18, 2014

FDA MedWatch - Merit Medical Systems, Custom Procedural Trays/Kits Containing 1 percent Lidocaine HCl Injection, 10mg/mL: Recall - Particulates Found in Hospira supplied Lidocaine

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Merit Medical Systems Custom Procedural Trays Kits Recall Particulates Found in Hospira Lidocaine

March 18, 2014

McKesson Technologies Anesthesia Care: Recall - Patient Case Data May Not Match Patient Data

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McKesson Technologies Anesthesia Care Recall Patient Case Data May Not Match Patient Data

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Hospira Hydromorphone Hydrochloride Injection

Friday, August 17, 2012

Audience: Risk Manager, Pharmacy

Issue: Hospira and FDA notified healthcare professional of a nationwide voluntraty 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, due to a reported complaint of a single Carpuject containing more than the 1 mL labeled fill volume. Opioid pain medications such as Hydromorphone have life-threatening consequences if overdosed. Those consequences can include respiratory depression (slowed breathing or suspension of breathing), low blood pressure and reduced heart rate including circulatory collapse.

Background:  The affected product is a prefilled glass cartridge for use with the Carpuject Syringe system. The affected lot number is 12720LL. The expiration date is December 1, 2013 and was distributed in March – May 2012.  Hospira has not received any reports of adverse events related to this issue for this lot.

Recommendations: 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.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch Safety Alert, including a link to the firm press release at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm315685.htm

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