FDA Provides Extended List of Hand Sanitizer Recalls

September 19, 2020

Each week, the FDA posts relevant recalls and other patient safety information. We highlight some of these notices that may be clinically relevant.

The US Food and Drug Administration has provided an updated and extended list of hand sanitizers consumers should avoid.

FDA POSTING:

FDA urges consumers not use certain hand sanitizer products

The following outlines the information on hand sanitizer labels for consumers to use to identify a product that:

  • Has been tested by FDA and found to contain methanol or 1-propanol.
  • Is labeled to contain methanol.
  • Has been tested and is found to have microbial contamination.
  • Is being recalled by the manufacturer or distributor.
  • Is subpotent, meaning it has less than the required amount of ethyl alcohol, isopropyl alcohol or benzalkonium chloride.
  • Is purportedly made at the same facility as products that have been tested by FDA and found to contain methanol or 1-propanol .

Read the full post.

Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Two Lots of NP Thyroid, Thyroid Tablets, USP Due to Sub Potency

FDA Publish Date:

September 17, 2020

Reason for Announcement:

Sub Potency

Company Name:

Acella Pharmaceuticals, LLC

Brand Name:

NP Thyroid 15 & NP Thyroid120

Description:

Acella Pharmaceuticals, LLC is voluntarily recalling one lot of 15-mg and one lot of 120-mg NP Thyroid®, Thyroid Tablets, USP [levothyroxine (T4) and liothyronine (T3)] to the consumer level. The products are being recalled because testing has found these lots to be sub potent. The product may have as low as 87% of the labeled amount of levothyroxine (T4). More information can be found at www.npthyroid.com/product-updatesExternal Link Disclaimer.

Risk Statement: Patients being treated for hypothyroidism (underactive thyroid), who receive sub potent NP Thyroid®, may experience signs and symptoms of hypothyroidism (underactive thyroid) which may include, fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight. There is reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism including early miscarriage, fetal hyperthyroidism, and/or impairments to fetal neural and skeletal development. In elderly patients and patients with underlying cardiac disease toxic cardiac manifestations of hyperthyroidism may occur, such as cardiac pain, palpitations or cardiac arrhythmia. To date, Acella has received four reports of adverse events for these lot numbers possibly related to this recall.

NP Thyroid®, Thyroid Tablets, USP is composed of levothyroxine and liothyronine, and used to treat hypothyroidism (underactive thyroid). The products subject to recall are packed in 100-count bottles. See product images.

Read the full recall statement.