HHP Medication Safety Watch: December 2020

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

Breast compress for people who are breastfeeding and skin treatment for infants who may have bacterial contamination

• Happy Ducts Compress (maker: WishGarden Herbs)
• Cord Care and Goldenseal Powder (maker: WishGarden Herbs)

Comment: Due to a possible supply chain contamination, certain lots of these products may contain a bacterium, Cronobacter sakazakii. Mothers or their infants could develop serious infections after exposure to this bacterium.

Happy Ducts Compress is applied to the breasts of a nursing person and is promoted as "a helpful external aid during lactation when lymph and immunity need extra support."

Cord Care Powder is applied to a newborn infant's skin and is promoted to help dry up the umbilical cord.

Topical anesthetic may have bacterial contamination

• Regenecare HA Topical Anesthetic Hydrogel (maker: MPM Medical, LLC)

Comment: One lot of this product has been recalled due to possible bacterial contamination with Burkholderia cepecia. This bacterium may cause a skin infection. Among people receiving chemotherapy or who have other causes of immune suppression, a potentially fatal bloodstream infection and bodywide infection (called sepsis) may develop.

Regenecare HA Hydrogel is an over-the-counter medication applied to the skin for pain relief or itching due to minor cuts or burns, insect bites, or other skin irritation.

Hand sanitizers may be contaminated with methanol (wood alcohol)

• IMC Wash-Free Hand Sanitizer (maker: Shane Erickson, Inc. DBA Innovative Marketing Consultants)

Comment: Drinking a product that contains methanol can cause vomiting, headache or blurred vision.  More severe toxicity includes permanent blindness, seizures, coma or death.  In rare cases, toxicity could develop from applying contaminated hand sanitizer to the skin. Infants and young children are at particular risk of accidental poisoning by these products. People with alcohol addiction and adolescents are also at high risk.

See additional FDA recalls and alerts for more than 200 hand sanitizer products in recent months due to methanol contamination or other issues.

Oral rinse may be contaminated with bacteria

• Paroex Chlorhexidine Gluconate Oral Rinse, 4 oz and 16 oz (maker: Sunstar Americas, Inc.)

Comment: This expands a recall from October 2020 that occurred after certain lots of this product were found to be contaminated with a bacterium called Burkholderia lata. Using this rinse could cause serious or even life-threatening infections (such as pneumonia), especially among those with a suppressed immune system. People with pre-existing lung disease, including pneumonia related to COVID-19, are particularly at risk.

This oral rinse is used to treat gum inflammation (gingivitis).
 

Prescription medicines

Two medications may be in the same bottle due to a packaging mix-up

• Sildenafil, 100 mg tablets (maker: AvKare)
• Trazodone, 100 mg tablets (maker: AvKare)

Comment: One lot of sildenafil and one lot of trazadone are being recalled due to a packaging error that may have caused these medications to be bottled together. A person prescribed one of these medicines could inadvertently take the other. This could cause unexpected side effects as well as not treating their health issue correctly.

Sildenafil is most commonly taken for erectile dysfunction and, less commonly, for circulation problems such as pulmonary hypertension. Sildenafil may cause a dangerous fall in blood pressure (especially if taken with nitrate medications) or other side effects, such as headache, flushing, or stomach upset.

Trazodone is approved for major depression and is often prescribed for insomnia as well. Trazodone may cause side effects such as sleepiness, constipation and blurry vision.

Blood thinner recalled due to failed quality control test

• Anagrelide Capsules, 1 mg (maker: Torrent Pharmaceuticals Limited)

Comment: One lot of this medicine was recalled because it failed to dissolve properly during quality control testing. This could cause slowed or incomplete release of the drug in the body, with resulting undertreatment. Because this drug is taken to prevent the excessive formation of blood clots in people with a blood disorder called thrombocythemia, undertreatment could lead to dangerous complications, including heart attack or stroke.

Read additional issues of HHP Medication Safety Watch