New Delhi: Glenmark Pharmaceuticals is recalling over 100,000 bottles of anti-inflammatory Indomethacin capsules from the US market due to incorrect instructions on the labelling, latest Enforcement report of the US regulator has said.
Glenmark Pharmaceuticals Inc USA is recalling 109,080 bottles of Indomethacin capsules USP, 50 mg, 100-count bottle, manufactured by Glenmark Pharmaceuticals at its Goa plant, United States Food and Drug Administration (USFDA) said.
The reason for the recall is, “Labelling: Incorrect Instructions: bottles incorrectly labelled with the usual adult dosage of one or two capsules 2 or 3 times a day,” rather than the correct usual adult dosage of ‘One capsule 2 or 3 times a day,’ the report said.
The ongoing nationwide voluntary recall is a class III recall, the regulator said.
As per the USFDA, a class III recall is initiated, “in a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.