Reported Apr 23, 2025 · Ongoing
Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), 1 x 100mL, Rx Only, Manufactured by: Gland…
Dr. Reddy's Laboratories, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Dr. Reddy's Laboratories, Inc. · 107 College Rd E · Princeton, NJ · 08540-6623
Is this the product you have?
- Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), 1 x 100mL, Rx Only
- Manufactured byGland Pharma Limited, Hyderabad, - 500 043 INDIA
- DistributorDr. Reddy's Laboratories Inc., Princeton, NJ 08540, NDC 43598-636-52
- Lot codes and dates
- Lot
A1540076Exp 08/31/2026
- Lot
- Amount recalled
- 4,010 bags
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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