Pfizer is voluntarily recalling five (5) lots of Accupril (Quinapril HCl) tablets distributed by Pfizer to the patient (consumer/user) level due to the presence of a nitrosamine, Nnitroso-quinapril, observed in recent testing above the Acceptable Daily Intake (ADI) level.
The NDC, Lot Number, Expiration Date, and Configuration details for these products are indicated in the tables below and photos of the products can be found at the end of this press release. The product lots were distributed nationwide to wholesalers and distributors in the United States and Puerto Rico from December 2019 to April 2022.
Accupril® (Quinapril HCl Tablets), 10 mg
Accupril® (Quinapril HCl Tablets), 20 mg
Accupril® (Quinapril HCl Tablets), 40 mg
|
NDC |
Lot Number |
Expiration |
Strength |
Configuration/ |
|---|---|---|---|---|
| 0071-0530-23 | 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
|
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