Class I
Ongoing
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
This recall is currently active, issued April 23, 2025. It was issued by Dr. Reddy'S Laboratories, Inc..
- Company
- Dr. Reddy'S Laboratories, Inc.
- Recall Initiated
- March 13, 2025
- Posted
- April 23, 2025
- Recall Number
- D-0365-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 4,010 bags
- Firm Location
- Princeton, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Nationwide in the USA
Lot / Code Info
Lot: A1540076, Exp 08/31/2026
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