DRUG RECALL - 1 gram Cefepime for Injection USP and Dextrose Injection USP used for Treatment of Infections
October 15, 2013, B. Braun Medical has issued a voluntary recall of 1 gram Cefepime for Injection USP and Dextrose Injection USP. B. Braun Medical issued the recall after visible organic particles were found in a reserve sample unit of the medication. The affected lot is H3A744, catalog 3193-11 with an expiration date of January 2015.
The particles found were identified as cotton and metal. If the particles go unnoticed, there is potential for severe injury.
1 gram Cefepime for Injection USP and Dextrose Injection USP is used to treat infections such as pheumonia, urinary tract infections, and skin infections.
Although no adverse health reactions have been associated with this recall, patients in possession of this product are asked to return it to the pharmacy or doctor’s office at which it was obtained. If you have any questions about this recall, please contact your local retail pharmacist or speak to your doctor.
For product replacement please contact B. Braun’s Customer Support at 1-800-227-2862, Monday through Friday, 8 a.m. to 7 p.m. EST.
Adverse events that may be related to the use of this product may also be reported to the United States Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting Program either online, by regular mail or by fax:
Online - www.fda.gov/medwatch/report.htm
Regular Mail - use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail the form to: MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
Fax - 1-800-FDA-0178