Sun Pharma recalls at least 34,000 bottles of generic drug
Mumbai-based pharma company, Sun Pharma, has announced that it is recalling over 34,000 bottles of a generic drug, diltiazem hydrochloride, from the US market. The drug is used for treating high blood pressure, angina and some types of irregular heartbeat.
This recall follows the FDA’s Enforcement Report, which saw ‘failed impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.’
This batch of the drug was produced at the company’s Halol-based manufacturing facility in Gujarat, and was later distributed on the US market by the company’s US unit.
Last month, the company announced a Class II nationwide recall in the US.
According to the FDA, a Class II recall is ‘a situation in which 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.’
In January, the company was noted by the FDA as having various lapses, including its failure to follow the correct written procedures, which have been designed to prevent microbiological contamination of drug products, at its Gurarat branch. The FDA’s warning letter also pointed out various other lapses at the Halol plant, which produces the company’s finished pharmaceutical products.