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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Pfizer voluntarily recalls bottles of Pristiqdue to tablet mix-up

Pfizer has initiated a voluntary recall for 220,761 bottles of the antidepressant Pristiq (desvenlafaxine) extended-release tablets 50 mg as a single 100 mg tablet of Pristiq Extended Release was found in a 50 mg bottle. However the company does not want to take any chances and so is recalling four lots of the antidepressant drug.Pfizer started the recall in mid-April.This was reported in the weekly Enforcement Report of the US Food and Drug Administration (FDA) for July 2, 2014.

Although, the risk of any other bottles being affected is less, Pfizer decided to recall as a precautionary measure as they were run on the same packaging line.

In March, Pfizer recalled two lots of different doses of Effexor XRand one lot of its Greenstone-branded Venlafaxine which added up to 104,450 bottles.The heart drug found in an Effexor XR bottle was Tikosyn, which is used to treat irregular heartbeats.