D-0365-2025 Class I Ongoing
FDA drug recall D-0365-2025 was initiated by Dr. Reddy's Laboratories, Inc. on March 13, 2025 and is designated Class I. 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 produc… The recall status is ongoing. Affected quantity: 4,010 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- April 23, 2025
- Initiation Date
- March 13, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,010 bags
Product 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
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 Pattern
Nationwide in the USA
Code Information
Lot: A1540076, Exp 08/31/2026