LISINOPRIL Recall D-1536-2022
Description: Lisinopril Tablets USP, 10 mg, 1000-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Nagpur- 441 108, India. NDC 68180-980-03
LISINOPRIL Recall D-1536-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1536-2022 |
| Event ID | 90859 |
| Brand | LISINOPRIL |
| Generic Name | LISINOPRIL |
| Manufacturer | LISINOPRIL |
| Original Package? | 1 |
| Active Substance | LISINOPRIL |
| Drug Route | ORAL |
| Distribution | Product was distributed to major distributors/wholesalers nationwide. |
| Quantity | 11,802 1000-count bottles |
| Recall Reason | Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet. |
| Drug Classification | Class II |
| Drug Code Info | 20220921 |
| Product NDC | 68180-512 68180-513 68180-517 |
| Drug UPC | 0368180517306 0368180979012 |
| Recall Initiation Date | 20220913 |
| Report Date | 20220921 |
| Classification Date | 20220915 |
| 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 | E7199S1YWR |
| Drug Application Number | ANDA077321 |
| Structured Product Labeling (SPL ID) | 133b3fec-07f6-41f5-9c7c-50b66c4c0677 |
| Structured Product Labeling (SPL Set ID) | 7d6c31e2-b5a4-4279-8013-a8dad37ea73b |
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