LEVETIRACETAM Recall D-0365-2025
Description: Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), 1 x 100mL, Rx Only, Manufactured by: Gland Pharma Limited, Hyderabad, - 500 043 INDIA, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, NDC 43598-636-52
LEVETIRACETAM Recall D-0365-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0365-2025 |
| Event ID | 96470 |
| Brand | LEVETIRACETAM |
| Generic Name | LEVETIRACETAM INJECTION |
| Manufacturer | LEVETIRACETAM INJECTION |
| Original Package? | 1 |
| Active Substance | LEVETIRACETAM |
| Drug Route | INTRAVENOUS |
| Distribution | Nationwide in the USA |
| Quantity | 4,010 bags |
| Recall Reason | LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL. |
| Drug Classification | Class I |
| Drug Code Info | 20250423 |
| Product NDC | 43598-635 43598-636 43598-637 |
| Product NUI | N0000008486 |
| Pharma Class (PE) | Decreased Central Nervous System Disorganized Electrical Activity [PE] |
| Recall Initiation Date | 20250313 |
| Report Date | 20250423 |
| Classification Date | 20250416 |
| Address | 107 College Rd E Princeton, NJ 08540-6623 United States |
| Recalling Firm | Dr. Reddy's Laboratories, Inc. |
| Unique Ingredient Identifier | 44YRR34555 |
| Drug Application Number | ANDA206880 |
| Structured Product Labeling (SPL ID) | f5cfc6e1-79f3-bd25-5f66-9ea05bc47def |
| Structured Product Labeling (SPL Set ID) | 0a9234b7-46b1-8e6c-a992-90f86cfb6e00 |
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