USFDA 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 nationwide (US) recall has been initiated by its Baltimore-based arm — Lupin Pharmaceuticals Inc, on July 17.
The USFDA 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 US market and does not impact any other markets.
Similarly, a US-based subsidiary of Mumbai-based 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 USFDA 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 the Indian market, remained unanswered.
Usually, domestic firms cater to the US and domestic markets from separate facilities.
This story has been published from economic times feed without modifications to the text.
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