HHP Medication Safety Watch: June 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

Dietary supplements for male sexual enhancement recalled due to contamination

• Launch Sequence capsules (maker: Loud Muscle Science, LLC)
• Launch Sequence Euphoria capsules (maker: Loud Muscle Science, LLC)
• Launch Sequence Aphrodisia capsules (maker: Loud Muscle Science, LLC)

Comment: Multiple lots of these products have been recalled after testing revealed they were contaminated with tadalafil, a prescription drug for erectile dysfunction. Tadalafil may cause serious side effects, including a dangerous drop in blood pressure. This risk is highest among people who are also taking heart medicines, such as nitroglycerin. A sudden and significant drop in blood pressure may cause heart attack, stroke, or death.

The recalled products are marketed as dietary supplements for male sexual enhancement.

Laxative recalled due to bacterial contamination

• CVS Health Magnesium Citrate Saline Laxative Oral Solution, Lemon Flavor (maker: Vi-Jon, LLC)

Comment: The makers of this product have recalled one lot after detecting Gluconacetobacter liquefaciens. This organism may cause serious and even life-threatening infections in people with an impaired immune system.

Magnesium citrate is a treatment for occasional constipation.

Nasal spray recalled due to bacterial contamination

• SnoreStop NasoSpray (maker: Green Pharmaceuticals Inc.)

Comment: Testing by the FDA discovered that one lot of this nasal spray was contaminated with a bacterium called Providencia rettgeri. While this organism doesn’t usually cause illness, it may cause a dangerous and even life-threatening infection, such as pneumonia or sepsis, in people with an impaired immune system.

This nasal spray is sold as a temporary remedy to reduce snoring.

Remedies for upset stomach recalled due to microbial contamination

• Major Milk of Magnesia 2400 mg/10 mL oral suspension (maker: Plastikon Healthcare, LLC)
• Major Milk of Magnesia 2400 mg/30 mL oral suspension (maker: Plastikon Healthcare, LLC)
• Major Milk of Magnesia 1200 mg/aluminum hydroxide 1200 mg/simethicone 120 mg per 30 mL oral suspension (maker: Plastikon Healthcare, LLC)
• Major Milk of Magnesia 2400 mg/aluminum hydroxide 2400 mg/simethicone 240 mg per 30 mL oral suspension (maker: Plastikon Healthcare, LLC)

Comment: Multiple lots of these products have been recalled due to microbial contamination. The recall notice offers no further details on the specific organism causing the problem. Use of these contaminated products could cause serious infections, especially among people with an impaired immune system.

The recalled products are marketed for symptoms of stomach upset, indigestion, heartburn, or bloating.

Over-the-counter arthritis remedy recalled due to prescription drug contamination

• Artri King Reforzado con Ortiga y Omega 3 (maker: Latin Foods Market)

Comment: The maker of this product has recalled one lot contaminated with two prescription anti-inflammatory drugs: diclofenac and dexamethasone. Diclofenac and dexamethasone can cause serious side effects, including heart problems, stomach ulcers, and kidney damage.

Artri King Reforzado con Ortiga y Omega 3 is sold as a dietary supplement to relieve the pain and inflammation of arthritis.

Children’s nasal swab allergy treatment recalled due to yeast and mold contamination

• Allergy Bee Gone for Kids Nasal Swab Remedy (maker: Buzzagogo, Inc.)

Comment: One lot of this product was recalled because FDA testing found elevated levels of yeast and mold. It also may contain the bacterium Bacillus cereus. Use of the recalled product could cause serious infections, including pneumonia, bloodstream infections, or sepsis, especially among people with an impaired immune system.

This product is marketed as a remedy to reduce seasonal allergy symptoms in children.

Prescription medicines

Opiate medication recalled due to incorrect labeling

• Bryant Ranch Prepack Morphine Sulfate 30 mg Extended-Release Tablets (maker: Bryant Ranch Prepack Inc.)
• Bryant Ranch Prepack Morphine Sulfate 60 mg Extended-Release Tablets (maker: Bryant Ranch Prepack Inc.)

Comment: Two lots of this product have been recalled, including one lot of 30 mg tablets and one lot of 60 mg tablets. The reason for the recall is a mix-up in labeling: bottles labeled as containing 30 mg tablets may instead contain 60 mg tablets, and those labeled as containing 60 mg tablets may instead contain 30 mg tablets.

For people who are supposed to be taking the 30 mg dose, inadvertent use of 60 mg tablets could lead to overdose and death. People prescribed the 60 mg dose who receive the 30 mg dose may experience inadequate pain control and symptoms of withdrawal.

This medicine is prescribed for severe pain.

Read additional issues of HHP Medication Safety Watch