HHP Medication Safety Watch: January 2022

This list contains selected items from the full FDA list of recalls, withdrawals, and alerts for medicines and certain health products. We've provided links to FDA information for each product and its maker. Unless otherwise noted, these actions apply only to the specific brand name of the product listed. Talk to your healthcare provider before stopping or changing any medicines or treatments that they have recommended for you.

• Over-the-counter products and medicines
• Prescription medicines

Over-the-counter products and medicines

Natural laxative recalled due to contamination with a microorganism

• AVpak Senna Syrup, 8.8mg/5mL (maker: Loxha LLC)

Comment: The maker of this product recalled one lot due to contamination with an infectious organism. Using this product could cause a life-threatening infection, especially for people who are elderly and those with a weakened immune system.

This product is sold as a natural vegetable laxative for treating occasional constipation.

Recall of supplement for male sexual enhancement due to contamination with prescription drug

• Hard Dawn Rise and Shine capsules (maker: Esupplementsales, LLC)

Comment: One lot of this product has been recalled because it was found to contain tadalafil, a prescription drug for erectile dysfunction (ED). Tadalafil may cause dangerously low blood pressure, especially for persons taking medicine containing nitrates (such as nitroglycerin or isosorbide).

The recalled product is sold as a treatment to enhance male sexual function.

Gel for wound care recalled due to bacterial contamination

• RevitaDerm Wound Care Gel, 1-ounce bottles and 3-ounce tubes (maker: Blaine Labs Company)

Comment: One lot of this product has been recalled due to contamination with a bacterium called Bacillus cereus. Applying this tainted gel to a wound could cause an infection in the skin or deeper tissues. Life-threatening infection and complications may occur, especially among premature newborns and people with a weakened immune system.

This gel is marketed as an antibiotic to prevent infection in skin wounds.

Prescription medicines

• Semglee Insulin glargine injection, 100 units/ml (U-100), 3mL prefilled pens (maker: Mylan Pharmaceuticals Inc.)

Comment: The maker of this product recalled one batch because the prefilled injection pens may not have labels. This could cause confusion about the name and dose of the medicine.

The risk of serious complications may be particularly high for people injecting more than one kind of insulin. Taking insulin injections improperly may lead to blood sugar levels that are too high or too low.

Semglee Insulin glargine is a form of long-acting insulin taken by people with type 1 or type 2 diabetes to improve blood sugar regulation.

Read additional issues of HHP Medication Safety Watch