HYDROCHLOROTHIAZIDE Recall D-0758-2022
Description: quinapril and hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets bottles, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-5225-9
HYDROCHLOROTHIAZIDE Recall D-0758-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0758-2022 |
| Event ID | 89864 |
| Brand | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE |
| 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 | 2442 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 | 59762-0220 59762-0222 59762-0223 |
| Product NUI | N0000175359 N0000175419 M0471776 |
| Drug UPC | 0359762022219 0359762022011 0359762321299 |
| 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) | 46a33cf7-f5c5-4afb-b464-27a36773fe52 |
| Structured Product Labeling (SPL Set ID) | a4985462-793f-45ab-bbee-43bc9d1135ce |
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