Pfizer recalls some lots of BP drug Accupril over presence of nitrosamine
New York: Pfizer has announced the voluntary recall of five lots of Accupril (Quinapril HCl) tablets distributed by Pfizer to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-quinapril, observed in recent testing above the Acceptable Daily Intake (ADI) level.
"Accupril has a safety profile that has been established over 30 years. To date, Pfizer is not aware of reports of adverse events that have been assessed to be related to this recall. Pfizer believes the benefit/risk profile of the products remains positive based on currently available data. Although long-term ingestion of N-nitroso-quinapril may be associated with a potential increased cancer risk in humans, there is no immediate risk to patients taking this medication. Patients currently taking the products should consult with their doctor or health care provider about alternative treatment options for them," the company stated.
The NDC, Lot Number, Expiration Date, and Configuration details for these products are indicated in the table below. The product lots were distributed nationwide to wholesalers and distributors in the United States and Puerto Rico from December 2019 to April 2022.
NDC | Lot Number | Expiration Date | Strength | Configuration/Count |
0071-0532-23 | DR9639 | 2023 MAR 31 | 10 mg | 1 x 90 count bottle |
0071-0532-23 | DX8682 | 2023 MAR 31 | 20 mg | 1 x 90 count bottle |
DG1188 | 2022 MAY 31 | 20 mg | 1 x 90 count bottle | |
0071-0535-23 | DX6031 | 2023 MAR 31 | 40 mg | 1 x 90 count bottle |
CK6260 | 2022 MAY 31 | 40 mg | 1 x 90 count bottle |
"Patients who are taking this product should consult with their healthcare provider or pharmacy to determine if they have the affected product," the company added.
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