Drug product
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
D-0365-2025
Product summary
- Event
- Event 96470
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 4,010 bags
- Official record key
drug-enforcement:D-0365-2025
Official wording
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.
Code information: Lot: A1540076, Exp 08/31/2026
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Labeling or packaging
LABELING: LABEL MIX-UP