QUINAPRIL HYDROCHLORIDE Recall D-0873-2022
Description: Accupril (Quinapril HCl Tablets) 20 mg, 90 Tablets, Rx only NDC 0071-0532-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017
QUINAPRIL HYDROCHLORIDE Recall D-0873-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0873-2022 |
| Event ID | 90064 |
| Brand | ACCUPRIL |
| Generic Name | QUINAPRIL HYDROCHLORIDE |
| Manufacturer | QUINAPRIL HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | QUINAPRIL HYDROCHLORIDE |
| Drug Route | ORAL |
| Distribution | Nationwide and Puerto Rico |
| Quantity | 10,304 bottles |
| Recall Reason | CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits. |
| Drug Classification | Class II |
| Drug Code Info | 20220525 |
| Product NDC | 0071-0527 0071-0530 0071-0532 |
| Drug UPC | 0300710530232 0300710527232 0300710532236 |
| Recall Initiation Date | 20220422 |
| Report Date | 20220525 |
| Classification Date | 20220516 |
| Address | 235 East 42nd Street New York, NY 10017-5703 United States |
| Recalling Firm | Pfizer Inc. |
| Initial Notification | Press Release |
| Unique Ingredient Identifier | 33067B3N2M |
| Drug Application Number | NDA019885 |
| Structured Product Labeling (SPL ID) | cd5fc1c5-7459-494c-b1d9-0064b6a4891d |
| Structured Product Labeling (SPL Set ID) | 63cf5651-d52c-4d27-9fd4-ed9cd9724dff |
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