IGMPI India

Sun Pharmaceuticals has issued a recall of about 400,000 bottles of anti-depressant and anti-allergic drugs in US for failing to meet specifications. The drugs are recalled as the pills failed to dissolve properly in the human body as designed. Sun Pharmaceutical Industries Limited is a multinational pharmaceutical company headquartered in Mumbai, Maharashtra that manufactures and sells pharmaceutical formulations and active pharmaceutical ingredients (APIs) primarily in India and the United States.

The company has recalled 1,28, 363 bottles of 5 mg Cetirizine Hydrochloride chewable tablets and another batch of 47,813 bottles of the same drug of 10 mg dosage prescribed for children. The recall of this anti-allergic drug is under Class III, defined as "a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences". According to FDA, the stability testing found that the product may not meet the drug release specification through expiry. The recall is being made by Caraco Pharmaceutical Laboratories, the US arm of Sun Pharma and the recalled drugs were manufactured at Sun Pharma's manufacturing facility in Gujarat.

The company has also recalled 1,60,105 bottles of generic Effexor, called Venlafaxine Hydrochloride extended release tablets of 150 mg strength and 91,777 bottles of 37.5 mg strength in the US market. This recall falls under class II, in which the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or the probability of serious adverse health consequences is remote. Both recalls were announced after public complaints.