PITAVASTATIN CALCIUM Recall D-0258-2025
Description: Livalo (pitavatstatin) tablets, 4 mg, 90-count bottles, Rx only, Manufactured by: Patheon, Inc. Cincinnati, OH 45237 USA or by Kowa Company, Ltd, Nagoya, 462-0024 Japan, Marketed by Kowa Pharmaceuticals: Kowa Pharmaceuticals America Inc., Montgomery, AL 36117 USA NDC 66869-404-90 HDPE Bottle, congregated into a shrink wrapped 6-pack further congregated into 24 6-packs in a cardboard case
PITAVASTATIN CALCIUM Recall D-0258-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0258-2025 |
| Event ID | 96379 |
| Brand | LIVALO |
| Generic Name | PITAVASTATIN CALCIUM |
| Manufacturer | PITAVASTATIN CALCIUM |
| Original Package? | 1 |
| Active Substance | PITAVASTATIN CALCIUM |
| Drug Route | ORAL |
| Distribution | PA, OH, and TX |
| Quantity | 5,328 Bottles |
| Recall Reason | Presence of foreign tablets/capsules |
| Drug Classification | Class III |
| Drug Code Info | 20250319 |
| Product NDC | 66869-104 66869-204 66869-404 |
| Drug UPC | 0366869404909 0366869104908 |
| Recall Initiation Date | 20250224 |
| Report Date | 20250319 |
| Classification Date | 20250307 |
| Address | 530 Industrial Park Blvd Montgomery, AL 36117-5543 United States |
| Recalling Firm | Kowa Pharmaceuticals America |
| Unique Ingredient Identifier | IYD54XEG3W |
| Drug Application Number | NDA022363 |
| Structured Product Labeling (SPL ID) | 8c680b64-3b3d-486d-b64b-a8645d925bba |
| Structured Product Labeling (SPL Set ID) | 44dcbf97-99ec-427c-ba50-207e0069d6d2 |
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