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Pfizer Accupril Hypertension Nitrosamine Recall Overview:
- Who: Pfizer has initiated a voluntary recall for five lots of its hypertension drug Accupril (Quinapril HCL) tablets.
- Why: The recall was initiated over concerns the Accupril tablets contain higher levels of the nitrosamine N Nitroso-quinapril than what is acceptable.
- Where: The recall is nationwide and in Puerto Rico.
Pfizer has voluntarily recalled five lots of its hypertension drug Accupril (Quinapril HCL) tablets over concerns they contain a higher-than-acceptable level of N Nitroso-quinapril, a nitrosamine.
The recalled Accupril (Quinapril HCL) tablets came in strengths of 10mg, 20mg and 40mg in 90-count bottles, according to a recall notice posted by the U.S. Food and Drug Administration on Apr. 22.
Pfizer initiated the recall after testing revealed the Accupril tablets contained higher levels of N Nitroso-quinapril than what is the Acceptable Daily Intake level, according to the Accupril recall.
The recalled Accupril tablets have expiration dates of either May 31, 2022, or March 31, 2023, and can be identified by their lot numbers DR9639, DX8682, DG1188, DX6031 or CK6260.
Pfizer says the recalled Accupril tablets were distributed to both wholesalers and distributors nationwide and to Puerto Rico between December 2019 and April 2022.
Wholesalers and distributors who have any of the recalled Accupril tablets are being urged to “stop use and distribution and quarantine the product immediately,” according to the Accupril recall.
Pfizer Tells Accupril Patients To Contact Healthcare Providers, Pharmacy
Pfizer is advising patients who are taking the Accupril tablets to talk to either their healthcare provider or pharmacy to determine whether they have the recalled product.
Any patients who have the recalled Accupril tablets should contact Sedgwick by phone at 888-345-0481 to obtain instructions on how to return the hypertension drug and receive financial reimbursement.
Healthcare professionals with questions, meanwhile, can contact Pfizer Medical Information by phone at 800-438-1985, option 3, or online, according to the Accupril recall.
Pfizer says reports of adverse events, meanwhile, should be directed to Pfizer Drug Safety by phone at 800-438-1985, option 1.
While nitrosamines are common in water and foods, being exposed to them at beyond acceptable levels over long periods of time can increase a person’s risk of cancer, according to the Accupril recall.
Pfizer says it has received no reports of adverse events connected to the recall and is reassuring consumers that there is “no immediate risk to patients taking this medication.”
Pfizer voluntarily recalled 11 lots of hypertension medications in March after discovering they contained too much nitrosamine.
Do you take Accupril (Quinapril HCL) tablets to help treat hypertension? Let us know in the comments!
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