HHP Medication Safety Watch: August 2020

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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

Hand sanitizers may be contaminated with methanol (wood alcohol)

Assured Hand Sanitizers (maker: Albek de Mexico S.A. de C.V.)
Bersih Hand Sanitizer Gel (maker: Soluciones Cosmeticas)
Command Brands Hand Sanitizer (maker: Roque Plast S.A. de C.V.)
Gelbac T Antibacterial Handgel (maker: Incredible Products Sa De Cv)
Jaloma Hand Sanitizer (maker: Laboratorios Jaloma S.A. de C.V.)
Medically Minded Hand Sanitizer (maker: Asiaticon SA de CV)
Modesa Hand Sanitizers (maker: Albek de Mexico S.A. de C.V.)
Next Hand Sanitizers (maker: Albek de Mexico S.A. de C.V.)
Nuuxsan Hand Sanitizers (maker: Albek de Mexico S.A. de C.V.)
See additional FDA recalls and alerts for more than 150 hand sanitizer products in recent months due to methanol or other issues

Hand sanitizers may be contaminated with 1-propanol

Harmonic Nature (maker: HARMONIC NATURE S. DE R.L. Mi)
Zanilast+ Hand Sanitizer (maker: Nanomateriales, SA de CV)
See additional FDA recalls and alerts for more than 150 hand sanitizer products in recent months due to 1-propanol or other issues

Comment: Some hand sanitizers have the wrong type or amount of alcohol. 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 due to the topical application of contaminated hand sanitizer. Drinking a product containing 1-propanol can cause sedation, coma, and death. 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.

Goldenseal root powder recalled due to microbial contamination

Maison Terre Goldenseal Root Powder (maker: Maison Terre)

Comment: The discovery of various microbial contaminants (and one infant death) has led to a voluntary recall of this powder. This product has been used as a treatment for a long list of ailments and conditions, ranging from the common cold and digestive disorders to hemorrhoids and liver disease. It has also been used in an effort to alter drug screening tests. No compelling evidence supports its effectiveness for any of these purposes.

Prescription medicines

Three nasal spray medications may deliver higher than expected doses

DDAVP Nasal Spray 10 mcg/0.1mL (maker: Ferring Pharmaceuticals US)
Desmopressin Acetate Nasal Spray 10 mcg/0.1mL (maker: Ferring Pharmaceuticals US)
STIMATE Nasal Spray 1.5 mg/mL (maker: Ferring Pharmaceuticals US)

Comment: These products are being voluntarily recalled because they may deliver higher than expected amounts of medication leading to overdose.

Desmopressin (brand name: DDAVP) is used to treat a rare condition called "central diabetes insipidus," which is not related to the more common diabetes mellitus. It is also used as a temporary treatment around the time of head trauma or surgery involving the pituitary gland. Too much of this medication may cause water retention and dangerously low blood sodium levels which may lead to seizure, coma or death.

Stimate nasal spray is another brand name version of desmopressin. It is used for the treatment for blood disorders, including certain cases of hemophilia A and von Willebrand's disease. Overdose may cause low blood sodium, seizure, coma, or death.

Metformin may be contaminated with a compound that may cause cancer

Metformin Hydrochloride Extended-Release Tablets, 500 mg and 750 mg (maker: Bayshore Pharmaceuticals, LLC)

Comment: Metformin is prescribed for type 2 diabetes. Certain batches of the medication contained a higher than acceptable level of N-Nitrosodimethylamine (NDMA), a known carcinogen (a compound that may cause cancer).

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HHP Medication Safety Watch: August 2020

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