No matter how stringent controlled environments are, there is still a risk of contamination in every batch of product. Making sure that recalls are executed appropriately is equally, very important
Despite every effort, sometimes contamination events do occur in cleanroom or controlled environments. Three contamination FDA recalls in January that were interesting to follow were from Fresenius Kabi, Nostrum Laboratories, and Essaar. The products recalled were an injection batch, a tablet batch, and a batch of rubbing alcohol respectively.
In early January 2021, Fresenius Kabi USA voluntarily recalled a single lot of Ketorolac Tromethamine Injection to the user level due to the presence of particulate matter.
Particulate matter was detected through reserve sample vials.
"Administration of products containing particulate matter could obstruct blood vessels and result in local irritation of blood vessels, swelling at the site of injection, a mass of tissue that could become inflamed and infected, blood clots travelling to the lung, scarring of the lung tissues, and allergic reactions that could lead to life-threatening consequences," stated the FDA announcement.
Later in January 2021, Missouri-based Nostrum voluntarily recalled one lot of Metformin HCl Extended Release Tablets to the consumer level. The tablets were found to contain levels of nitrosamine impurities above the ADI limit of 96 ng/day, as published in the FDA Guidance Document issued in September 2020. This is an expansion of the recall initially announced on 2 November 2020.
"NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables," stated the FDA announcement.
The month also saw Essaar voluntarily recalling a lot of Soho Fresh 70% Rubbing Alcohol to the consumer level. FDA analysis of the product revealed it is contaminated with methanol.
"Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning," stated the FDA announcement.
As all of these contamination events were recalled voluntarily, all three companies are following similar protocols for preventing the products reaching and harming end users.
Fresenius, Nostrum, and Essar are all notifying distributors of the products, either by letter or by email. Both Nostum and Essar are also arranging for return of all recalled products. Fresenius is also advising returning the product but gave further instruction for distributors to "notify their customers and direct them to quarantine and discontinue distributing or dispensing the affected lot, and to return the product to Fresenius Kabi".
Thankfully there has been no adverse advents reported from any of these recalls.