Greenpark Compounding Pharmacy produced and distributed compounded products from Prescription Labs Inc. nationwide. These products are intended to be sterile and could be life-threatening if used when not sterile.
FDA discovered in July/August that the conditions of Greenpark Compounding Pharmacy’s facility could be causing contamination to the compounded drugs they were manufacturing. On August 18 and 31, 2021, the compounder initiated a recall for several lots of an ophthalmic drug product. September 2, Greenpark was advised to recall all of the lots for this product—sterile or not; the risk was too high.
FDA has yet to receive any notice about adverse reactions to this ophthalmic product.
Tracking and tracing correct data information is extremely important with situations like this. All lots were recalled due to an unknown. It was unknown if this compounded product was produced or inspected properly, without any data alterations.
With InQuest Science’s Identifier system, major product recalls and incidents—such as Greenpark Compounding—will be reduced and controlled. Data integrity will force inspection to be done properly, making sure the manufacturing company is following all USP<790> and USP1790> rules and regulations. This system will easily trace all lots that need to be recalled, all the way down to the individual product that is defected. With unlimited data storage, information will never become lost or untraceable.
