Major thyroid med recall underway
Both recalls are due to sub-potency of drugs that treat hypothyroidism.
In the second recall of thyroid medications this month, Acella Pharmaceuticals is recalling one lot of its NP Thyroid due to sub-potentcy.
Earlier this month, RLC Labs issued a nationwide recall of all lots of its Nature-Throid and WP Thyroid, also due to sub-potency.
The RLC Labs recall applies to 483 lots of the pharma maker’s Nature-Throid and WP Thyroid in all strengths, all counts of product within current expiry to the consumer level.
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FDA testing of samples from six lots found them to be sub-potent. The product may have as low as 87% of the labeled amount of Liothyronine (T3) or Levothyroxine(T4), RLC said in a press release.
Patients being treated for hypothyroidism who receive sub-potent Nature-Throid or WP Thyroid may experience signs and symptoms of hypothyroidism 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, RLC said.
Nature-Throid and WP Thyroid (thyroid tablets, USP), packaged in 30, 60, 90, 100 and 1,000-count bottles, were distributed nationwide to retail pharmacies and healthcare professionals.
RLC Labs, Inc. is proactively notifying its wholesalers by email, mail, and phone to discontinue distribution of the product being recalled and is arranging for the return of all recalled products.
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However, patients who are currently taking the medications should not discontinue use without contacting their healthcare provider for further guidance and/or replacement prescription, the company said.
Acella said its recall applies to one lot of 15 mg. and one lot of 120 mg. NP Thyroid, Thyroid Tablets, USP [levothyroxine (T4) and liothyronine (T3)] , which was distributed 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),” Acella said in a press release.
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