New Delhi, Jan 02, 2015: Drug firms Wockhardt, Cadila Healthcare and Hospira are voluntarily recalling certain lots of drugs in the US, according to the US Food and Drug Administration (FDA).
As per information available on the US drug regulator’s website, Wockhardt USA Inc, the US-based arm of the company, is recalling 11,18,400 Metoprolol Succinate extended-release tablets, a hypertension drug, for ‘failed dissolution specifications’.
The tablets have been manufactured by Mumbai-based Wockhardt Ltd and distributed by Wockhardt USA LLC.
The nationwide recall has been initiated by the company on April 17 this year and initiated under Class-III which FDA defined as “a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences”.
Zydus Pharmaceuticals USA Inc, the US-based arm of Ahmedabad-based Cadila Healthcare is recalling 58,920 bottles of Benzonatate Capsules, used to treat coughs, due to “wet and/or leaking capsules”.
The recall has been initiated by the company on November 26 and has been initiated under Class-II, which FDA states as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences.
The capsules have been manufactured by Ahmedabad-based Cadila Healthcare and distributed by Zydus Pharmaceuticals USA.
Hospira is recalling 2,61,706 vials of Meropenem, an antibiotic, in the US, Puerto Rico, Italy, the Netherlands and Spain for having a “defective container”.
“Glass vials may crack due to low (thin) out of specification vial wall thickness which may lead to contamination and lack of assurance of sterility,” FDA said.
The vials were manufactured by Hospira Healthcare India for Hospira, Inc. The recall has been initiated by the company on October 24 and has been initiated under Class-II.
Comments from the companies could not be obtained immediately. PTI
