Generic drugmakers Viatris and Aurobindo have initiated new product recalls, the FDA revealed this week.
Viatris is asking for the return of one lot of octreotide acetate injection because of the possible presence of glass particles. The recall was triggered by a customer complaint of particulate matter and is to the pharmacy and hospital level. There have been no subsequent reports of adverse events.
The lot was manufactured by Italfarmaco SpA and distributed in the United States between January and June of this year, carrying an expiration date of March 2024. The drug is packaged in cartons of ten 1 ml syringes, dispensing a 500 mcg/mL dose.
The drug helps control diarrhea and flushing episodes that occur with intestinal tumors. It also is used to reduce growth hormone levels in acromegaly patients.
Use of the product containing glass particles could lead to local irritation, swelling and other complications, the company warns. Viatris adds that the probability of exposure to this danger is low.
Viatris has been haunted by three recalls of its biosimilar to Sanofi’s diabetes blockbuster Lantus. The most recent came in July over the potential for the label to be missing on some prefilled pens.
As for the Aurobindo recall, it concerns two batches of quinapril and hydrochlorothiazide tablets due to high nitrosamine levels. The recall is to the customer level.
Aurobindo began shipping the lots in May of 2021, with an expiration of January 2023. The company has not received any reports of adverse events. Quinapril and hydrochlorothiazide are a fixed-combination tablet used to lower blood pressure.
Nitrosamine concerns have triggered a range of recalls across the pharma industry in recent years. Other companies affected by nitrosamine recalls include Novartis, Pfizer and many others.