IGMPI India

October 7, 2015

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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Recall of Class 2 Medicines(Mitoxantrone 2mg/ml Concentrate) for Solution

Hospira UK limited has recalled a number of batches of Mitoxanthrone due to a number of confirmed out of specification test results obtained during stability studies.The batches were recalled due to adverse impurity profile and low potency.

The recalled batch numberalong with their details are provided in the table below:

Batch Number	Expiry Date	Pack Size	First Distributed
Z054636AB	Dec 2014	1 x 10ml	18 Feb 2013
A014636AB	Apr 2015	1 x 10ml	14 Oct 2013
A024636AD	Jul 2015	1 x 10ml	31 Mar 2014

Remaining stock of the affected batches would be quarantined and customers who have already received the affected batches are being contacted to arrange for collection of the same through their primary wholesaler.