Dr. Reddy’s recalls levetiracetam infusion bags nationwide due to mislabeling

Dr. Reddy’s Laboratories has initiated a voluntary recall of Levetiracetam in 0.75% Sodium Chloride Injection (1,000 mg/100 mL), identified as Lot Number A1540076. The issue involves mislabeling of infusion bags that were incorrectly marked as containing 500 mg/100 mL of the medication rather than 1,000 mg/100 mL.

This discrepancy may lead to the administration of double the intended dose. The problem was identified after distribution, prompting a nationwide recall. The affected infusion bags were shipped between November 4 and November 6, 2024, through hospitals, pharmacies, and distributors across the United States. The company has not reported any adverse events at this time. As part of the recall, the product is being removed from circulation, and replacements or refunds are being offered to impacted purchasers.

What to look for?

Product name and description:

• Levetiracetam in 0.75% Sodium Chloride Injection (1,000 mg/100 mL)
• Packaged in infusion bags labeled incorrectly as Levetiracetam in 0.82% Sodium Chloride Injection (500 mg/100 mL)

Identifiers:

• Lot Number: A1540076
• The lot number is printed on the infusion bag’s label
• Correct strength is 1,000 mg/100 mL, despite the 500 mg/100 mL labeling

Affected purchase locations and dates:

• Distributed nationwide through hospitals, pharmacies, and medical distributors
• Shipped from November 4, 2024, through November 6, 2024

What should buyers do?

Product handling:

• Return the affected infusion bags to the original purchase source or follow the instructions provided by Dr. Reddy’s Laboratories
• Do not administer the mislabeled product under any circumstance

Refunds, replacements, or repairs:

• Contact Inmar for a prepaid return label or refund at 1-877-645-1584
• Customer service is available Monday through Friday from 9 AM to 5 PM EST

Health and safety advice:

• Seek medical attention if you believe you or someone under your care has received the mislabeled medication
• Watch for potential adverse effects such as dizziness, somnolence, respiratory issues, or other indications of overdose

Sources

• FDA recall notice
• Business Wire announcement
• CNBC TV18 coverage
• Stock Titan notice
• NDTV Profit article