FDA Announces Two Product Recalls Over Concerns of Particulates and Impurities

In two separate announcements, the FDA relayed press releases from Aurobindo USA and Viatris reporting recalls for their respective products. Two lots of Aurobindo’s blood pressure and hypertension medicine, Quinapril and Hydrochlorothiazide combination tablets, contained an unacceptable amount of nitrosamine, a possible carcinogen. Viatris recalled a lot of Octreotide Acetate injections due to a customer complaint concerning glass particulates found on the tips of syringes. 

Nitrosamine’s Recurring Impact on Pharmaceuticals

According to its press release, Aurobindo recalled two lots of Quinapril and Hydrochlorothiazide combination tablets due to concerns about nitrosamine levels. Nitrosamines are organic compounds often found in water and foods like meat. While low levels of nitrosamines are not harmful, extended exposure to higher levels can increase cancer risks. 

Aurobindo recalled one lot of 20 mg tablets and another 15 mg lot. The tablets are round-shaped, film-coated, pink, and debossed with ‘D’ on the scored side and ‘19’ on the other. Aurobindo supplies the medication in 90’s HDPE bottles. The company distributed the tablets in May 2021, and the medication expires in January 2023.

Qualanex, Aurobindo’s contracted logistics company, will notify all distributors and customers by phone and in writing to notify them of the immediate discontinuation of distribution. Aurobindo has not received any reports of adverse events related to the recall.

Nitrosamine has impacted several companies in the pharmaceutical industry, causing safety concerns and product recalls. In August, Merck discovered its diabetes medication, Januvia, contained nitrosamine. However, instead of a recall, the FDA decided to allow the continued distribution of the product to avoid product shortages.

Related Article: FDA Finds Carcinogen In Merck’s Diabetes Drug, Allows Continued Sales To Avoid Shortage

Glass Particulates on Viatris’ Syringes

In a separate recall event, Viatris recalled a lot of Octreotide Acetate injections due to glass particulates found on the tips of syringes. The drug treats diarrhea associated with metastatic carcinoid tumors and reduces blood levels of growth hormone and insulin growth factor-1. 

A customer complaint shed light on the problem, prompting Viatris to take action and cease distributing the affected lot. Italfarmaco SpA manufactured the lot before Mylan Institutional LLC distributed the products in the U.S. between January 11 and June 21 this year. The products expire in March 2024. 

Glass particulates on syringes can cause swelling, allergic reactions, microvascular obstruction, pulmonary embolism, and more. Fortunately, no adverse effects from the affected lot have been reported. 

Viatris notified distributors by phone and in writing to cease distribution of the affected lot. The company urged wholesalers and retailers to examine their inventory and immediately pull products matching the lot number to schedule a return of the products. 

Pharmaceutical recalls are a necessary safety barrier within the industry. Aurobindo and Viatris’ most recent recalls indicate a system designed to keep the public safe. With so many variables in the pharmaceutical manufacturing process, companies and regulatory agencies must remain vigilant to maintain public safety. 

Author

Reed Slater