Acella Pharmaceuticals Announces Recall of Thyroid Medication Because of Threat to Unborn Babies and Other Side Effects
WASHINGTON, D.C. — Acella Pharmaceuticals, LLC (Acella), with the consent of the U.S. Food and Drug Administration (FDA) announced it would recall thirteen lots of NP Thyroid ® because one of the two active ingredients is super-potent. The generic name for the recalled drugs is thyroid tablets, USP. The company claimed in a press release that it discovered the super-potency through in-house testing. The tests revealed that the recalled pills contain the active ingredient identified by Acella as Liothyronine (T3) at levels as high as 115% over the amount noted on the drug label. Acella was informed about two adverse events suffered by patients who ingested the super-potent drug. The company did not discuss the nature of the events or the severity of the effects taking the defective drug had on the patients.
Acella identified the possible side effects a patient could experience after consuming the recalled medication. Acella said that taking the super-potent pills could lead to hyperthyroidism. Symptoms of hyperthyroidism include rapid heart rate, increased blood pressure, fatigue, weight loss, heat sensitivity, chest pain, muscle weakness, and disturbed heart rhythms. Any cardiac symptoms could be fatal.
Pregnant women must avoid consuming the recalled drug. Taking the super-potent drug could be fatal to a woman’s unborn baby. The woman could experience a miscarriage, or the unborn child could sustain other prenatal injuries.
Acella said that the thirteen lots of NP Thyroid ® recalled are in 100-unit bottles containing either 30-mg, 60-mg, or 90-mg tablets. Acella also said that the recall is to the consumer level. Designating the recall to the consumer level means that pharmacies have distributed the recalled prescription drugs to patients outside of hospital settings. Therefore, anyone who is taking NP Thyroid ® tablets must contain his or her physician for directions to avoid taking the defective drug safely.
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