As of September 23rd, 2019, MacLeods Pharmaceuticals has recalled 31,968 bottles of pioglitazone hydrochloride in the U.S. People who take this medication should contact their doctor or talk to a representative of the pharmaceutical company for advice.
The U.S. Food and Drug Administration (FDA) released an enforcement report stating that the affected tablets had been found to be “superpotent,” potentially increasing the risk of adverse health issues to patients taking the drug. The subsidiary Macleods Pharmacy USA Inc. subsequently voluntarily recalled the drug.
Pioglitazone hydrochloride tablets are used to control high blood sugar levels in patients with type 2 diabetes mellitus, along with diet and exercise. Adverse effects from the “superpotent” drug are believed to be temporary or medically reversible, and the probability of serious health problems is remote, but patients are advised to seek an alternative medication or advice from a doctor about whether it is safe to continue their prescribed medication.
The tablets affected by this class II recall were manufactured at Macleod’s facility at Baddi in Himachal Pradesh and shipped to eight distributors. They have been sold in various places throughout the U.S.
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The affected drugs were sold under the brand Actos in 15-mg doses. If you take pioglitazone hydrochloride or Actos in 15-mg doses, please contact your doctor to find a replacement drug if possible.
If you take this drug and believe you are experiencing an adverse reaction, please report your symptoms to the FDA via the MedWatch website.Whizzco