FDA announces recall of contaminated antibiotic

Posted at 2:26 PM, Dec 26, 2017
and last updated 2017-12-26 14:26:00-05

(RNN) - A pharmaceutical company has issued a recall of an injectable antibiotic that contains mold. The problem was discovered when a product complaint led to the discovery of a white, particulate matter floating in a flexible bag containing the drug.

AutoMedica Pharma LLC is recalling one lot of Linesolis Injection 600/300mL flexible bags that was distributed from May 15 through Aug. 14, 2017.

The use of a non-sterile injectable product can result in fatal infections in a broad array of patients, the FDA said in its recall notice. So far, Automedica has not received any reports of adverse events or identifiable safety concerns attributed to the recall, the release stated.

The oaxasolidinone-class antibacterial is used in adults and children for the treatment of bacterial infections including several types of pneumonia, foot infections related to diabetes and other causes; skin and skin structure lesions and other infections that are resistant to other antibiotics.

Consumers with questions about the recall can contact Autobindo Customer Service weekdays from 9 a.m. to 5 p.m. ET at 1-866-850-2876.

If you need help returning your product or have questions about the recall process, contact Inmar at 1-800-967-5952 weekdays from 8:30 a.m. to 5 p.m. ET.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online.

 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

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

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