METHYLPREDNISOLONE Recall D-0752-2022
Description: Methylprednisolone Tablets, USP 4mg, 100-count bottle, Rx Only, Manufactured by: Jubliant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-001-06
METHYLPREDNISOLONE Recall D-0752-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0752-2022 |
| Event ID | 89923 |
| Brand | METHYLPREDNISOLONE |
| Generic Name | METHYLPREDNISOLONE |
| Manufacturer | METHYLPREDNISOLONE |
| Original Package? | 1 |
| Active Substance | METHYLPREDNISOLONE |
| Drug Route | ORAL |
| Distribution | Nationwide in the USA and Puerto Rico |
| Quantity | 19,222 Bottles (100-count) |
| Recall Reason | Subpotent |
| Drug Classification | Class III |
| Drug Code Info | 20220413 |
| Product NDC | 59746-001 59746-002 59746-003 |
| Product NUI | N0000175576 N0000175450 |
| Drug UPC | 0359746003142 0359746001032 0359746002046 |
| Pharma Class (EPC) | Corticosteroid [EPC] |
| Recall Initiation Date | 20220401 |
| Report Date | 20220413 |
| Classification Date | 20220406 |
| Address | 207 Kiley Dr Salisbury, MD 21801-2249 United States |
| Recalling Firm | Jubilant Cadista Pharmaceuticals, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | X4W7ZR7023 |
| Drug Application Number | ANDA040189 |
| Structured Product Labeling (SPL ID) | f7ee0424-d881-4ae1-98be-e8863a8f78fe |
| Structured Product Labeling (SPL Set ID) | 7bf4d3d3-3f8a-4e20-9194-061658efca61 |
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