New Delhi, October 12 (IANS). Two major Indian pharmaceutical companies, Dr Reddy’s Laboratories and Zydus Lifesciences, are recalling some medicines from the US market. The US Food and Drug Administration (USFDA) has reported that some problems have been found in these medicines during the manufacturing process. In such a situation, these medicines are being recalled to ensure the safety of the patients.
Dr. Reddy’s US branch has decided to recall 571 vials of Succinylcholine Chloride Injection. This medicine is used to relax the muscles.
The USFDA said the drug was found to be outside quality standards during a six-month investigation, prompting the recall. This batch of this drug is being recalled across the US. This case is under a Class-2 recall, which means that the use of this drug may cause temporary or reversible health problems, but the serious health risks are very rare.
Similarly, Zydus Pharmaceuticals (USA), the American arm of Zydus Lifesciences, has also recalled more than 1,500 boxes of Entecavir tablets. Entecavir is an antiviral drug, which is mainly used in the treatment of a disease called chronic hepatitis B.
The USFDA reported that problems related to impurities and spoilage were found in this drug. Due to this, 912 bottles of 0.5 mg and 600 bottles of 1 mg Entecavir tablets have been recalled from the market.
India has the largest number of factories manufacturing medicines as per USFDA standards, which are located outside America.
This is not the first time that Indian pharmaceutical companies have had to recall their medicines from America. Even before this, many companies have recalled medicines due to quality or production related reasons.
Sun Pharma, Lupine and Dr Reddy’s have earlier recalled similar medicines. Their main objective has been to give priority to the safety of patients.
Also in July this year, Mumbai-based Sun Pharmaceutical Industries had recalled 5,448 bottles of a drug used to treat Attention Deficit Hyperactivity Disorder (ADHD). This medicine was Lisdexamfetamine Demesylate Capsules. The drug failed to meet the required solubility standards in the required tests, due to which the company took this step keeping in mind the safety of its customers.
–IANS
PK/AS
