Thousands of bottles of a popular and widely-used cholesterol drug are being voluntarily recalled for “Failed Dissolution Specifications,” which suggests the drugs did not properly dissolve at a standard rate and could lead to a reduction in the drug’s effectiveness.
According to an enforcement report from the Food and Drug Administration, 141,984 bottles of Atorvastatin Calcium Tablet — a generic for Lipitor — which were manufactured by Alkem Laboratories, were recalled by distributor Ascend Laboratories Sept. 19.
Oct 10, the recall was classified as a “Class II,” which means the product, “may cause temporary or medically reversible adverse health consequences,” or where the probability of serious adverse health consequences is remote.
The recalled products were issued by prescription only, the FDA said, and came in doses of 10 mg, 20 mg, 40 mg and 80 mg.
The drugs were distributed nationwide, contain a variety of lot codes and expiration dates which can be found here. It wasn’t immediately clear how the recall impacts patients taking the pills, and no further details about the recall were provided.
Ascend Laboratories did not immediately respond to NBC Chicago’s request for comment.
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