HYDROCHLOROTHIAZIDE Recall D-0755-2022
Description: Accuretic (quinapril HCl/hydrochlorothiazide) Tablets 10 mg/12.5 mg 90 tablets bottle, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0222-23
HYDROCHLOROTHIAZIDE Recall D-0755-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0755-2022 |
| Event ID | 89864 |
| Brand | ACCURETIC |
| Generic Name | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE |
| Manufacturer | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE |
| Original Package? | 1 |
| Active Substance | HYDROCHLOROTHIAZIDE QUINAPRIL HYDROCHLORIDE |
| Drug Route | ORAL |
| Distribution | Nationwide |
| Quantity | 160 bottles |
| Recall Reason | CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit. |
| Drug Classification | Class II |
| Drug Code Info | 20220413 |
| Product NDC | 0071-0220 0071-0222 0071-0223 |
| Product NUI | N0000175359 N0000175419 M0471776 |
| Drug UPC | 0300717225230 0300715212232 0300710222236 |
| Pharma Class (PE) | Increased Diuresis [PE] |
| Pharma Class (EPC) | Thiazide Diuretic [EPC] |
| Pharma Class (CS) | Thiazides [CS] |
| Recall Initiation Date | 20220321 |
| Report Date | 20220413 |
| Classification Date | 20220406 |
| Address | 235 East 42nd Street New York, NY 10017-5703 United States |
| Recalling Firm | Pfizer Inc. |
| Initial Notification | Press Release |
| Unique Ingredient Identifier | 33067B3N2M 0J48LPH2TH |
| Drug Application Number | NDA020125 |
| Structured Product Labeling (SPL ID) | 1d3fab62-2114-4d5b-b07a-9b0f2b5a3efd |
| Structured Product Labeling (SPL Set ID) | 80e9d61d-9674-4ac4-b84c-79a875d408dd |
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