America’s Unsafe Medical Products

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Apotex Drospirenone and Ethinyl Estradiol Tablets
> Issue date: March 1, 2019
> Type of alert: Recall

Apotex is recalling four lots of its Drospirenone and Ethinyl Estradiol tablets because the blister packaging may contain defective or empty blisters. The error could cause patients to miss taking a tablet or to take a placebo tablet instead, resulting in a loss of efficacy.

Expanded Recalls of Valsartan and Losartan
> Issue date: March 1, 2019
> Type of alert: Update

AurobindoPharma USA has expanded its voluntary recall to include 38 additional lots of its valsartan and amlodipine-valsartan combination tablets. Torrent Pharmaceuticals also expanded its recall of losartan potassium and losartan potassium/hydrochlorothiazide combination tablets to an additional 144 lots. Both recalls are related to contaminated products.

Angiotensin Receptor Blockers (ARBs)
> Issue date: February 28, 2019
> Type of alert: Update

The FDA has updated its limits for interim acceptable intake limits for impurities in a number of ARB products, including Valsartan, Losartan, Irbesartan and others.

Robotically Assisted Surgical Devices for Mastectomy Procedures
> Issue date: February 28, 2019
> Type of alert: Safety communication

The FDA is informing health care providers and patients that the safety and effectiveness of these devices has not been established either for mastectomy procedures or cancer prevention: “There is limited, preliminary evidence that the use of robotically assisted surgical devices for treatment or prevention of cancers that primarily (breast) or exclusively (cervical) affect women may be associated with diminished long-term survival.”

Physio-Control LIFEPAK 15 Monitors/Defibrillators
> Issue date: February 27, 2019
> Type of alert: Recall

Physio-Control has recalled 8,164 monitor/defibrillators to update the system’s firmware. The device may lock up (blank monitor while power indicators are lighted and no response from the keypad and no device functions). This is a Class I recall, meaning that continued use of these devices may cause serious injury or even death.

Golean Detox Capsules
> Issue date: February 25, 2019
> Type of Alert: Recall

Golean Detox USA voluntarily has issued a recall of all lots of its capsules following an FDA analysis that the capsules are tainted with substances that have been withdrawn by the agency from the U.S. market. The company said it has received no reports of adverse effects related to the recall.