QUINAPRIL HYDROCHLORIDE Recall D-0089-2023
Description: Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-558-09
QUINAPRIL HYDROCHLORIDE Recall D-0089-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0089-2023 |
| Event ID | 91279 |
| Brand | QUINAPRIL |
| Generic Name | QUINAPRIL |
| Manufacturer | QUINAPRIL |
| Original Package? | 1 |
| Active Substance | QUINAPRIL HYDROCHLORIDE |
| Drug Route | ORAL |
| Distribution | Product was distributed by major distribution chains nationwide. |
| Quantity | 23,736 |
| Recall Reason | CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit. |
| Drug Classification | Class II |
| Drug Code Info | 20221228 |
| Product NDC | 68180-554 68180-556 68180-557 |
| Drug UPC | 0368180556091 |
| Recall Initiation Date | 20221207 |
| Report Date | 20221228 |
| Classification Date | 20221223 |
| Address | Harborplace Tower111 S Calvert St Fl 21st Baltimore, MD 21202-6174 United States |
| Recalling Firm | Lupin Pharmaceuticals Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 33067B3N2M |
| Drug Application Number | ANDA077690 |
| Structured Product Labeling (SPL ID) | a05f8d04-435a-4157-9b50-febe11b1ab1a |
| Structured Product Labeling (SPL Set ID) | 8ded0773-3aec-4e89-9836-d22a5a84abf0 |
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