HHP Medication Safety Watch: December 2021

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

Cold and flu remedy recalled due to contamination

• Rompe Pecho CF (maker: Efficient Laboratories, Inc.)
• Rompe Pecho EX (maker: Efficient Laboratories, Inc.)
• Rompe Pecho MAX (maker: Efficient Laboratories, Inc.)
• Rompe Pecho DM (maker: Efficient Laboratories, Inc.)

Comment: The maker of these products is recalling certain lots because of possible contamination with bacteria or other infectious agents. Use of contaminated products could cause illness with symptoms of vomiting and diarrhea. This expands a 2020 recall to include additional lots.

These products were sold in 2019 and are used to treat symptoms of the common cold and flu.

Prescription medicines

Steroid ointment recalled due to contamination with bacteria

• Clobetasol Propionate ointment, 0.05% (maker: Taro Pharmaceuticals USA, Inc.)

Comment: One batch of this skin treatment has been recalled because a bacterium called Ralstonia pickettii was detected during routine product testing. This bacterium is found in soil or water and doesn’t usually cause disease in healthy people. However, it may give people with reduced immune function or skin disease (such as psoriasis or sunburn) serious infections, including pneumonia or septic shock.

Clobetasol is a prescription medicine applied to the skin to treat skin inflammation caused by conditions such as allergic reactions, eczema, or psoriasis.

Metformin recalled due to a cancer-causing contaminant

• Metformin hydrochloride, extended-release tablets, 750 mg (distributor: Viona Pharmaceuticals, Inc.)

Comment: Certain lots of this drug contain a higher than acceptable level of N-Nitrosodimethylamine (NDMA), which is classified as a probable carcinogen (a compound that may cause cancer).

Metformin is prescribed for type 2 diabetes.

In recent months, the FDA has issued recalls regarding more than 250 products containing metformin. See this link for the full list.

Heart medicine recalled due to possible malfunction of spray device

• Perrigo Nitroglycerin Lingual Spray, 12 g bottle (maker: Padagis US LLC)

Comment: Several lots of this medicine have been recalled because the spray device may not deliver the medicine when needed. This medicine is sprayed under the tongue to treat chest pain due to coronary artery disease. Failure of the device may lead to unrelieved chest pain requiring evaluation and treatment in an emergency room.

Compounding pharmacy recalls all compounded drugs provided to consumers

• 70 medicines (note: automatic download) ranging from antibiotics to corticosteroids (maker: Edge Pharma, LLC)

Comment: Edge Pharma, LLC is recalling 70 medicines because of "process issues" in their preparation that could lead to lack of sterility or other problems that affect quality and safety. Using these medicines may cause serious infections or other unexpected side effects, or they may be ineffective.

As noted in the FDA press release, you can identify the affected products by their label, which has the name and logo of Edge Pharma, LLC.

Injectable blood thinner recalled due to high temperature exposure

• Enoxaparin Injection (maker: Sandoz)

Comment: One lot of enoxaparin sodium (40 mg/0.4 mL Single-Dose Syringes) has been recalled due to possible exposure to high temperatures during shipment. This may lessen the drug’s effectiveness.

Because enoxaparin is prescribed for a number of serious conditions (such as blood clots in the lung or leg), lower effectiveness could lead to life-threatening complications.

Read additional issues of HHP Medication Safety Watch