Medications & Supplements/Prescription Drugs

Hetero Labs, Ltd. - Unit III: Levetiracetam Oral Solution Recalled Due to Presence of a Foreign Substance (Screw)

Agency Publication Date: August 21, 2018

Summary

Hetero Labs, Ltd. is recalling 4,050 bottles of Levetiracetam Oral Solution, USP (100 mg/mL), which is a prescription medication used to treat seizures. This recall was initiated because a foreign object—specifically a screw—was discovered in the product. The affected medication was manufactured for Camber Pharmaceuticals, Inc. and distributed in 16 fl oz (473 mL) bottles in New Jersey.

Risk

The presence of a foreign object like a metal screw in liquid medication poses a significant risk of choking or internal injury if swallowed. Additionally, the presence of such a substance indicates a potential failure in the manufacturing quality control process which could affect the integrity of the medicine.

What You Should Do

Check your medicine bottle to see if it is Levetiracetam Oral Solution, USP, 100 mg/mL in a 16 fl oz (473 mL) bottle (NDC 31722-574-47).
Look for Lot # E170346 with an expiration date of 02/19 printed on the label to determine if your specific bottle is part of the recall.
If you have the affected medication, stop using it immediately and contact your healthcare provider or pharmacist for guidance on obtaining a replacement and continuing your treatment safely.
Return any unused product to the pharmacy where you purchased it for a refund.
Contact the manufacturer, Hetero Labs, Ltd., for further instructions regarding this recall.
For additional questions or to report a problem, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare consultation and pharmacy refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Levetiracetam Oral Solution, USP, 100 mg/mL (16 fl oz / 473 mL)

Model:

NDC 31722-574-47

Recall #: D-0099-2018

Lot Numbers:

E170346 (Exp 02/19)

Date Ranges: Expiration date 02/19

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78287

Status: Resolved

Manufacturer: Hetero Labs, Ltd. - Unit III

Sold By: Camber Pharmaceuticals, Inc.

Manufactured In: India

Units Affected: 4050 bottles

Distributed To: New Jersey

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Check your medicine bottle to see if it is Levetiracetam Oral Solution, USP, 100 mg/mL in a 16 fl oz (473 mL) bottle (NDC 31722-574-47).

Look for Lot # E170346 with an expiration date of 02/19 printed on the label to determine if your specific bottle is part of the recall.

If you have the affected medication, stop using it immediately and contact your healthcare provider or pharmacist for guidance on obtaining a replacement and continuing your treatment safely.

Return any unused product to the pharmacy where you purchased it for a refund.

Contact the manufacturer, Hetero Labs, Ltd., for further instructions regarding this recall.

For additional questions or to report a problem, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.