Weekly, we identify which FDA recall announcements might be most clinically relevant.
The US Food and Drug Administration (FDA) regularly posts updates on recalls, outbreak investigations, and related regulatory activities like these.
Weekly, we identify which of those announcements might be most clinically relevant.
(Below are excerpts taken from official FDA postings)
RLC Labs, Inc., Issues Voluntary Nationwide Recall of All Lots of Nature-Throid® and WP Thyroid with Current Expiry Due to Sub Potency
RLC Labs, Inc. is voluntarily recalling a total of 483 lots of Nature-Throid® and WP Thyroid® in all strengths, all counts of product within current expiry to the consumer level.
The products are being recalled because testing of samples from six (6) lots by the U.S. Food and Drug Administration found the samples to be sub potent.
The product may have as low as 87% of the labeled amount of Liothyronine (T3) or Levothyroxine(T4).
Risk Statement: Patients being treated for hypothyroidism (underactive thyroid), who receive sub potent Nature-Throid® or WP 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. RLC Labs, Inc. has not received any reports of adverse events related to this recall.
Nature-Throid® and WP Thyroid® (thyroid tablets, USP) is composed of liothyronine and levothyroxine, and are used to treat hypothyroidism (underactive thyroid). The products subject to recall are packaged in 30, 60, 90, 100 and 1,000 count bottles.
Open Book Extracts Issues Voluntary Nationwide Recall of All Lots of Always Be Clean Hand Sanitizer and Just Hand Sanitizer that are Labeled to Contain Methanol
Open Book Extracts (OBX) is voluntarily recalling to the consumer level all lots of Always Be Clean Hand Sanitizer and Just Hand Sanitizer that are labeled to contain methanol.
Risk Statement: Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.
OBX sources hand sanitizer from a leading global chemical and ingredient distributor, and has verified through a third-party lab that the hand sanitizer does not contain reportable levels of methanol. The supplier updated the Safety Data Sheet (SDS) to remove methanol since it is below the reportable level, and we updated the labels accordingly.