New Delhi: Hyderabad-based Dr Reddy’s Laboratories, Glenmark Pharma, and Zydus are recalling products in the US market for manufacturing issues, according to the US Food and Drug Administration (USFDA).
In its latest enforcement report, the US health regulator said Princeton-based Dr Reddy’s Laboratories Inc, a unit of the Hyderabad-based drug firm, is recalling 1,656 bottles of Montelukast sodium tablets.
The product is indicated to prevent wheezing, breathing difficulty, chest tightness, and coughing caused by asthma in adults.
Presence of foreign tablets, capsules
As per the USFDA, the company is recalling the affected lot due to “the presence of foreign tablets and capsules”.
A foreign tablet was found in a bottle of Montelukast sodium tablets, USP 10 mg, identified as metoprolol 25 mg, it added.
The company initiated the Class II voluntary recall on 13 October this year.
The USFDA noted that Mahwah-based Glenmark Pharmaceuticals Inc, USA, a unit of Mumbai-based Glenmark Pharma, is recalling 5,856 bottles of Deferasirox tablets for oral suspension.
The product is used to treat hemochromatosis, or iron overload in the blood. The company is recalling the affected lot due to “failed dissolution specifications,” the USFDA noted.
The company initiated the Class II recall on 20 October this year.
Failed dissolution specifications
Glenmark Pharmaceuticals Inc is also recalling 16,944 bottles of Ranolazine Extended-Release tablets, used to treat chronic chest pain, in the US due to “failed dissolution specifications,” the USFDA stated.
The company initiated the Class II nationwide recall on 23 October 2023.
The US health regulator noted that Zydus Pharmaceuticals (USA) Inc is recalling a certain number of Oxybutynin Chloride extended-release tablets in different strengths due to “failed dissolution specifications-out-of-specification test results.”
The affected lot was manufactured by Cadila Healthcare Ltd, Baddi, Himachal Pradesh, it added.
The company initiated the Class II recall on 19 October this year.
As per the USFDA, a Class II recall is initiated in a situation in which the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.