Drug manufacturers Pfizer and Sandoz have recalled multiple lots of medication due to the presence of nitrosamine impurities. Pfizer’s recall affects select lots of Accuretic® (quinapril HCl/ hydrochlorothiazide) and two authorized generics (quinapril and hydrochlorothiazide, and quinapril HCl/ hydrochlorothiazide tablets) from Greenstone. Sandoz is recalling 13 lots of orphenadrine citrate 100mg extended release (ER) tablets.

• There is minimal impact to members through Benecard Central
• Nitrosamines are probable human carcinogens with the potential to cause cancer if an individual is exposed to them above acceptable levels over a long period of Pfizer and Sandoz identified nitrosamines above the FDA-established Acceptable Daily Intake level in the recalled medications.
• Pfizer: Accuretic and the authorized generics included in the recall are used to treat hypertension (high blood pressure). Pfizer had received no reports of adverse events related to the affected products as of the recall The company has stated there is no immediate risk to patients using the affected medications, and that the benefit/risk profile of the products remains positive.
• Sandoz: Orphenadrine citrate ER tablets are indicated as an adjunct to rest, physical therapy, and other measures to relieve discomfort associated with acute painful musculoskeletal conditions. Sandoz had received no reports of adverse events related to the affected lots as of the recall
• The FDA has made details of both recalls available on its website, including instructions on identifying the affected lots and next steps for The Pfizer announcement can be found here, and the Sandoz recall notice is located here.