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Glenmark recalls 100,000 bottles of drug over incorrect instrictions

The ongoing nationwide voluntary recall is a class III recall

Press Trust of India  |  New Delhi 

Pharmaceuticals, drugs, pharma industry, medical, health, lab

is recalling over 100,000 bottles of Indomethacin capsules from the US market due to incorrect instructions on the labelling, latest Enforcement report of the US regulator has said.

Inc USA is recalling 109,080 bottles of Indomethacin capsules USP, 50 mg, 100-count bottle, manufactured by at its Goa plant, (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.

(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

First Published: Thu, April 05 2018. 18:00 IST
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