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Recall Observatory FDA recall evidence

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

March 13, 2025

Class I

Product summary

Firm
Dr. Reddy's Laboratories, Inc.
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

    reason.labeling_packaging · v1.0.0

    LABELING: LABEL MIX-UP