Recalls That Should Be on Your Radar—Week of February 23, 2020

We’ve compiled a list of recalls issued by the US Food and Drug Administration (FDA) and US Department of Agriculture (USDA) from this past week:

King Systems Issues Recall of King Vision Video Laryngoscope Adapter Size ½ Due to Image Reversal

King Systems has issued a recall of its King Vision Video Laryngoscope Adapter due to the possibility that impacted lot numbers feature left/right reversed imagery on the device’s display.

The device is used to aid in placing a tracheal tube and examine a patient’s upper airway. The image may appear normal, and so use of the affected products may result in serious adverse consequences or extend the time to place the trachea tube.

There have been no reported injuries or deaths to date.

Read the recall statement.

Tytek Medical Issues Recall of TM-317 PneumoDart-Pneumothorax Needle Due to Fully and Partially Blocked Needles

Tytek Medical has issued a recall of its PneumoDart-Pneumothorax Needle due to the possibility of blocked needles. The problem arises due to the presence of adhesive from the assembly process.

The product is used during life threatening situations such as lung trauma.

Needle blockage can lead to delay in emergency treatment, leading to the risk of additional injury or death.

Tytek has received one complaint, and zero reports of injuries or deaths.

Read the recall statement.

American Health Packaging Issues Voluntary Recall of Ranitidine Tablets Due to N- nitrosodimethylamine Impurity

American Health Packaging has issued a voluntary recall of 11 lots of Ranitidine tablets, tsp 150 mg, 100 count to the consumer level. The affected products may contain levels of N-Nitrosodimethylamine (NDMA) levels above those established by the FDA.

NDMA is a probable human carcinogen. No reports of adverse events have been reported to date.

Ranitidine is indicated for short term treatment of active duodenal ulcers, maintenance therapy for duodenal ulcer patients, short term treatment of benign gastric ulcers, and more.

Read the recall statement.

Med Man Expands Recall of Up2 and Bow & Arrow Due to Undeclared Sildenafil

In November 2019, Med Man Distribution issued a voluntary recall of Up2 dietary supplement. The recall has now been expanded to cover all lots of Bow & Arrow libido enhancer for men.

FDA laboratory testing showed that the dietary supplements contained undeclared sildenafil, an FDA approved prescription drug for erectile dysfunction. The presence of the drug renders the supplements unapproved drugs for which safety has not been established, making them subject to recall.

Read the recall statement.

Taro Pharmaceuticals USA Issues Recall of Phenytoin Oral Suspension Due to Possible Underdosing or Overdosing

Taro Pharmaceuticals USA has issued a recall for 2 lots of Phenytoin Oral Suspension USP to the consumer level. The product is indicated for treatment of tonic-clonic and psychomotor seizures.

The problem arises because the oral suspension may not resuspend when shaken, as instructed for administration, which can result in under or overdosing. Infants and young children are most susceptible to adverse health events as a result of this problem, but there have been no reported adverse reactions thus far.

Read the recall statement.