Mumbai-based Wockhardt is recalling about 1,62,142 cartons of various drugs from US market, after the American health regulator has pointed out its deviations in maintaining the current good manufacturing practices (CGMP) laid by it.
"Firm did not adequately investigate customer complaints," the USFDA said. All the drugs being recalled by the company have been manufactured at its Mumbai-based facility and distributed in the US by its subsidiary, Wockhardt USA. The company is recalling 97,837 cartons of 20 mg Famotidine tablets, used to treat ulcers in stomach and intestines.
Wockhardt is also recalling 24,496 cartons of Amlodipine besylate tablets and 25,357 cartons of Lisinopril tablets, both medicines used to treat high blood pressure, in various strengths for non-adherence of CGMP norms. The company is also recalling 5,464 cartons of Azithromycin tablets and 3,572 cartons of Clarithromycin tablets, both antibiotic drugs, for deviation from CGMP norms. Further, the Mumbai-based drug firm is recalling 5,416 cartons of Zonisamide capsules, used to treat certain types of seizures, in the US market.
An email query sent to the company over the matter remained unanswered. The recalls have been classified as 'Class-II' by the FDA, which is defined as "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 May, Wockhardt had recalled 93,393 bottles of Captopril tablets, used for treating high blood pressure and kidney problems caused by diabetes,for failing to meet specifications for thickness.