FDA Recalls You Should Know About—Week of May 13, 2018

Here’s a list of the latest recalls issued by the US Food and Drug Administration (FDA) from this past week that you should have on your radar:

Medtronic Recalls MindFrame Capture LP Revascularization Device

The device, intended to restore blood flow or get rid of blood clots within a blood vessel in the brain during an acute ischemic stroke in patients who are not eligible for or fail intravenous tissue plasminogen activator therapy, is being recalled due to wire material that may break or separate during use.

The FDA has deemed this a Class I recall, which is the most serious, as the use of these devices could cause result in serious injury or even death.

For more information, be sure to read the official announcement.

MBI Distributing, Inc. Recalls Several Products Due to a Lack of Process Controls

MBI Distributing, Inc. has issued a voluntary recall for all lots of the following products: homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir. The products are being recalled because they have been found to be manufactured with a lack of adequate controls.

Products without proper process controls could vary in strength, quality, and purity. As such, they could potentially result in an adverse reaction, especially in vulnerable populations such as infants and children.

For more information, be sure to read the official press release.

7K and Poseidon 4500 Issues Voluntary Recall Due to Presence of Undeclared Sildenafil and/or Tadalafil

An FDA analysis found that samples of 7K and Poseidon 4500 were found to contain undeclared Sildenafil and/or Tadalafil, active ingredients in 2 FDA-approved prescription drugs for the treatment of erectile dysfunction.

Use of the products could cause a significant drop in blood pressure that could potentially be deadly.

For more information, be sure to read the official announcement.

Apotex Corp. Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection

Apotex Corp. has issued a voluntary recall of 36 lots of Piperacillin and Tazobactam for injection, USP 3.375 gram/vial and 4.5 gram/vial strengths to the consumer/user level. The products are being recalled because they have been found to contain elevated levels of impurities that may result in decreased potency.

Decreased potency could result in making infections worse, and in extreme circumstances, could lead to serious morbidities depending on the severity of the illness.

For more information, be sure to read the official press release.

Vyaire Medical Recalls AirLife Resuscitation Devices and Broselow Convenience Kits

The Vyaire Medical AirLife Resuscitation Device & Broselow Convenience Kit are manual resuscitation devices that are used together to provide constant ventilation to adults and children who cannot adequately breathe or are not breathing at all on their own.

The product is being recalled due to an error in its product design that could potentially result in difficulty or the inability to disconnect the mask from the elbow of the resuscitator.

For more information, check out the official press release.