Lupin, Sun Pharma Recall Drugs In The U.S. Market
Mumbai-based Lupin is recalling 11,688 bottles of Lisinopril tablets USP, 10 mg, which is used to treat high blood pressure, as per the latest Enforcement Report by the US health regulator.
U.S. FDA said the company is recalling the specific number of bottles due to the presence of foreign tablets.
Lisinopril tablets USP, (20 mg) were found in a 1,000 count bottle of Lisinopril Tablets USP (10 mg), it noted.
The tablets have been manufactured at Lupin's Nagpur facility and the recall has been initiated by its Baltimore-based arm -- Lupin Pharmaceuticals Inc, on July 17.
The U.S. FDA has classified it as a Class-II recall, which is initiated in 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".
When contacted, a company spokesperson said the recall is limited to the U.S. market, and does not impact any other markets.
Similarly, a U.S.-based subsidiary of Sun Pharma is recalling 3,516 bottles of antiepileptic drug, Clonazepam orally disintegrating tablets.
The USFDA listed the reason for the recall as "cross contamination with other products".
The New Jersey-based Sun Pharmaceutical Industries, Inc initiated the nationwide recall on July 6.
The U.S. FDA has classified the action as a Class-III recall, which is initiated in a situation "in which use of or exposure to a violative product is not likely to cause adverse health consequences."
A mail sent to the company, asking if the recall would have any impact in Indian market, remained unanswered.
Usually, domestic firms cater to the U.S. and domestic markets from separate facilities.