IGMPI India

October 7, 2015

PAN Drugs receives warning letter from USFDA

MHRA issues recall notice of Lacri-Lube eye ointment

Another Import Ban for Polydrug Laboratories

Health Canada lifts its ban from two Apotex facilities in India

33 drugs were found to be of not of standard quality during Surprise inspection

Vivimed Labs successfully completes USFDA inspection of its manufacturing facility

October 7, 2015

PAN Drugs receives warning letter from USFDA

USFDA has recently issued a warning letter to PAN drugs Vadodara based plant due to significant deviations from good manufacturing practices.

MHRA issues recall notice of Lacri-Lube eye ointment

The Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a recall notice to Allergen Limited. The recall notice relates to 5g and 3.5g pack sizes of

Another Import Ban for Polydrug Laboratories

USFDA (Food and Drug Administration) issues import ban for products manufactured by Polydrug Laboratories. It was issued on Sept. 11, 2015 for

Health Canada lifts its ban from two Apotex facilities in India

Health Canada has lifted its ban from Apotex two Indian facilities. Canada’s drug regulator reinspected the two plants in June and determined

33 drugs were found to be of not of standard quality during Surprise inspection

Recently Karnataka drug control department had conducted surprise inspections to pick up drug samples at random. The drug test labs have issued their result.

Vivimed Labs successfully completes USFDA inspection of its manufacturing facility

Vivimed Labs has recently successfully completed inspection of its API manufacturing facility in Spain. After the completion of inspection Vivimed said “the USFDA inspectors concluded

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Pure Edge Nutrition recalls Bella Vi brand products due to undeclared Sibutramine and Phenolphthalein

Pure Edge Nutrition issued a nationwide voluntary recall of Bella Vi brand products due to undeclared Sibutramine and Phenolphthalein. The company recalled one lot of each: Bella Vi Insane Bee Pollen Capsules, Bella Vi BTrim Ultimate Boost, Bella Vi BTrim Max, Bella Vi Extreme Accelerator, Bella Vi Insane Amp’d, and two lots of Bella Vi Amp’d Up, to the consumer level.

Sibutramine was removed from the US market in October 2010 for safety reasons and Phenolphthalein is used as laxative and is not approved for marketing in US. So these products are unapproved new drugs. The products containing these drugs can harm the consumers because Sibutramine can increase blood pressure and/or pulse rate in some patients and may present a risk for those with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. These products can also interact in life threatening ways with other medications a consumer may be taking. Till date, company has not received any complaint of adverse reactions related to this recall.