Indian drug manufacturer Wockhardt recalls over 1.62 lakhs cartons of drugs in US
Drug firm Wockhardt is recalling 1,62,142 cartons of various drugs in the US market due to deviations in current good manufacturing practice norms laid down by the American health regulator. The drugs being recalled were used in the treatment of ailments like high blood pressure and ulcer.
As per information available on the US Food and Drug Administration’s (USFDA) website, Mumbai-based Wockhardt is recalling the drugs for current good manufacturing practice (CGMP) deviations. “Firm did not adequately investigate customer complaints,” the USFDA said.
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”.
All the drugs being recalled by the company were manufactured at its Mumbai-based facility and distributed by Wockhardt USA, the company’s US subsidiary.
The company is recalling 97,837 cartons of 20 mg Famotidine tablets, used to treat ulcers in stomach and intestines. Also being recalled are 24,496 cartons of Amlodipine besylate tablets and 25,357 cartons of Lisinopril tablets, both of which are 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. In addition, the firm is recalling 5,416 cartons of Zonisamide capsules, used to treat certain types of seizures, in the US market.
This is the second time this year that Wockhardt is recalling drugs manufactured by them. In May, the company had recalled 93,393 bottles of Captopril tablets, used for treating high blood pressure and kidney problems caused by diabetes after having failed to meet specifications for thickness.
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