New Delhi : Jubilant Cadista Pharmaceuticals Inc, part of the Jubilant Group, is recalling over 1,500 bottles of glucocorticoid Methylprednisolone tablets in the US market due to incorrect labelling.
Jubilant Cadista Pharmaceuticals Inc is recalling 1,512 bottles of Methylprednisolone tablets USP 16 mg, 50-count bottles on account of incorrect labelling, latest Enforcement Report by the United States Food and Drug Administration (USFDA) has said.
The reason for the recall is, “Labelling: Incorrect or Missing Lot and/or Exp Date: incorrect expiration date of 02/0218 is printed on the container label instead of the correct expiration date of 02/2018,” it added.
The voluntary ongoing nationwide and Puerto Rico recall is a class III recall, the report said.
As per the FDA, 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”.
Glucocorticoid is a hormone that predominantly affects the metabolism of carbohydrates and to a lesser extent, fats and proteins.
Methylprednisolone tablets are used in treatment of endocrine disorders, rheumatic disorders, dermatologic diseases, allergies and ophthalmic diseases and respiratory diseases among others.