USA — The FDA has relayed press releases from Aurobindo USA and Viatris reporting product recalls in two separate announcements.
Two lots of Aurobindo’s blood pressure and hypertension medication, Quinapril and Hydrochlorothiazide combination tablets, contained an unacceptable level of nitrosamine, a potential carcinogen.
Viatris on its part recalled a large number of Octreotide Acetate injections due to a customer complaint about glass particulates found on the tips of syringes.
Aurobindo recalled two lots of Quinapril and Hydrochlorothiazide combination tablets due to nitrosamine concerns, according to a press release.
Nitrosamines are organic compounds that are commonly found in water and foods such as meat. While low levels of nitrosamines are not harmful, prolonged exposure to higher levels can increase the risk of cancer.
Aurobindo’s contracted logistics company, Qualanex, will notify all distributors and customers by phone and in writing of the immediate suspension of distribution. Aurobindo has received no reports of adverse events as a result of the recall.
Nitrosamine has had an impact on several pharmaceutical companies, causing safety concerns and product recalls.
Merck discovered nitrosamine in its diabetes medication Januvia in August. Instead of issuing a recall, the FDA decided to allow the product’s continued distribution in order to avoid product shortages.
In a separate recall, Viatris recalled a large number of Octreotide Acetate injections due to glass particulates found on syringe tips.
The medication alleviates diarrhea caused by metastatic carcinoid tumors and lowers blood levels of growth hormone and insulin growth factor-1.
A customer complaint brought the issue to light, prompting Viatris to take action and stop distributing the affected lot.
Italfarmaco SpA produced the lot before Mylan Institutional LLC distributed it in the United States between January 11 and June 21 of this year. The products will be phased out in March 2024.
Glass syringe particulates can cause swelling, allergic reactions, microvascular obstruction, pulmonary embolism, and other complications. Fortunately, no adverse effects have been reported from the affected lot.
Viatris notified distributors by phone and in writing that the affected lot would no longer be distributed.
The company urged wholesalers and retailers to examine their inventory and pull products matching the lot number as soon as possible in order to schedule a return of the products.
Pharmaceutical recalls are a necessary industry safety barrier. The recent recalls of Aurobindo and Viatris point to a system designed to keep the public safe.
Companies and regulatory agencies must remain vigilant to ensure public safety with so many variables in the pharmaceutical manufacturing process.
A drug recall is the most effective way to protect the public from a defective or potentially harmful product.