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.
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