PENICILLAMINE Recall D-0148-2024
Description: Penicillamine Tablets USP 250 mg, 100-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 Manufactured by: Lupin Limited, Nagpur-441 108, India, NDC# 70748-153-01
PENICILLAMINE Recall D-0148-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0148-2024 |
| Event ID | 93482 |
| Brand | PENICILLAMINE |
| Generic Name | PENICILLAMINE |
| Manufacturer | PENICILLAMINE |
| Original Package? | 1 |
| Active Substance | PENICILLAMINE |
| Drug Route | ORAL |
| Distribution | Product was distributed to 3 wholesale/distributor accounts. |
| Recall Reason | Failed Dissolution Specifications |
| Drug Classification | Class II |
| Drug Code Info | 20231220 |
| Product NDC | 70748-153 |
| Product NUI | N0000175713 |
| Drug UPC | 0370748153017 |
| Pharma Class (EPC) | Antirheumatic Agent [EPC] |
| Recall Initiation Date | 20231122 |
| Report Date | 20231220 |
| Classification Date | 20231213 |
| 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 | GNN1DV99GX |
| Drug Application Number | ANDA212933 |
| Structured Product Labeling (SPL ID) | 99f3ca78-1663-47a1-9ed3-9c4eaa9f0271 |
| Structured Product Labeling (SPL Set ID) | f6ecaf47-902f-4378-b524-7a88f20ba138 |
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