Tag Archives: voluntary recall

Sanofi US Issues Voluntary Nationwide Recall of Auvi-Q® Due to Potential Inaccurate Dosage Delivery

Sanofi US Issues Voluntary Nationwide Recall of Auvi-Q® Due to Potential Inaccurate Dosage Delivery

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Sanofi US Issues Voluntary Nationwide Recall of Auvi-Q® Due to Potential Inaccurate Dosage Delivery
10/28/2015 09:38 PM EDT

Sanofi US is voluntarily recalling all Auvi-Q (epinephrine injection, USP). The recall involves all Auvi-Q currently on the market and includes both the 0.15 mg and 0.3 mg strengths for hospitals, retailers and consumers. This includes lot number 2299596 through 3037230, which expire March 2016 through December 2016. The products have been found to potentially have inaccurate dosage delivery.

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Voluntary Recall Of Chariot Guiding Sheath

Voluntary Recall Of Chariot Guiding Sheath

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Boston Scientific (NYSE: BSX) has voluntarily recalled the Chariot™ Guiding Sheath globally. These devices are intended for the introduction of interventional devices during peripheral vascular procedures, and were recalled on November 19th due to the risk of shaft separation.

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Drug Information Update – FDA alerts health care professionals not to use sterile drug products from Qualgen

Drug Information Update – FDA alerts health care professionals not to use sterile drug products from Qualgen
FDA Division of Drug Information: Know the Moment It Happens

The Division of Drug Information (DDI) is CDER’s focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of lots 1 through 67 of non-expired drug products intended to be sterile produced and distributed nationwide by Qualgen LLC, in Edmond, Okla., due to lack of sterility and quality assurance. The recalled products were compounded prior to September 1, 2015.

Health care professionals should immediately check their medical supplies, quarantine any drug products marketed as sterile from Qualgen or Amerilab LLC, the facility’s former name, and not administer them to patients. Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.

During FDA’s recent inspection of Qualgen’s facility, investigators observed insanitary conditions, including poor sterile production practices, which raise concerns about Qualgen’s ability to assure the sterility of drug products that it produced.

On October 8, 2015, FDA recommended that Qualgen cease sterile operations until appropriate corrective actions have been implemented by the facility, and recall all non-expired drug products intended to be sterile. On October 9, 2015, Qualgen informed FDA that it would voluntarily recall certain lots of non-expired drug product marketed as sterile. However, the company refused to cease sterile compounding operations. Therefore FDA alerts health care professionals and patients not to use drug products marketed as sterile from Qualgen.

For more information, please visit: Qualgen