New american norms force Wockhardt to withdraw over 50 lakh bottles of drugs

Deviations in current good manufacturing practice norms laid down by the American health regulator has prompted Wockhardt to recall over 50 lakh bottles of various drugs, used for treating ailments like high blood pressure and ulcer, in the US market.

As per the information available on the US Food and Drug Administration's (USFDA), Mumbai-based Wockhardt is recalling the drugs for current good manufacturing practice (CGMP) deviations.

"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 over 5.47 lakh bottles of Amlodipine Besylate tablets, used for treating high blood pressure, in various strengths. It is also recalling over 6.32 lakh bottles of Lisinopril tablets, which is also used to treat hypertension.

Besides, the company is also recalling over 4.86 lakh bottles, over 15,000 cartons and over 800 pouches of blood pressure lowering drug Metoprolol succinate extended-release tablets in the US market.

Further, it is is also recalling over 4.8 lakh bottles of Captopril tablets, used to lower blood pressure in various strengths in the US market.

The company is also recalling over 2 lakh bottles and 848 pouches of lansoprazole tablets, used to treat ulcers stomach and intestinal ulcers. It is also recalling over 7.33 lakh bottles of Famotidine tablets in the US market.

Wockhardt is recalling over 3.77 lakh bottles of Zolpidem tartrate tablets, used to treat insomnia. It is also recalling over 5.78 lakh bottles, 571 pouches and 1,62,953 cartons of antibiotic drug azithromycin tablets.

The company is also recalling over 6.43 lakh bottles of epilepsy drug zonisamide capsules. Wockhardt is also recalling 59,729 bottles of clarithromycin tablets, over 4 lakh bottles of tamsulosin hydrochloride capsules and 53,894 bottles of extended Phenytoin Sodium capsules.

Wockhardt is also recalling 5,910 bottles of lamotrigine extended-release tablets.

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".

Last month, Wockhardt had recalled 1,62,142 cartons of various drugs in the US market.

(Image credits: Indiatimes)