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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Camber Lacosamide Oral Solution Recalled for Failed Quality Specifications

Agency Publication Date: December 28, 2022
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Summary

Camber Pharmaceuticals, Inc. has recalled several lots of Lacosamide Oral Solution (lacosamide), a prescription medication used to treat seizures. The recall was initiated because the product failed quality testing for the amount of p-Hydroxybenzoic Acid, an inactive ingredient used as a preservative. No injuries or adverse incidents have been reported in connection with this recall.

Risk

The level of p-Hydroxybenzoic Acid was found to be outside of the required specifications, which may affect the medication's stability and preservative effectiveness over time. This could potentially reduce the quality of the drug.

What You Should Do

  1. This recall affects Lacosamide Oral Solution, USP, CV, 10mg/mL (NDC 31722-627-26) sold in 200 mL bottles.
  2. Check your medication label for lot numbers E222200 (Exp 05/2024), E222199 (Exp 05/2024), or E222228 (Exp 06/2024).
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Camber Pharmaceuticals, Inc. for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Lacosamide Oral Solution, USP, CVby Camber Pharmaceuticals, Inc.
Variants: 10mg/mL, 200 mL bottle
Lot Numbers:
E222200 (Exp 05/2024)
E222199 (Exp 05/2024)
E222228 (Exp 06/2024)
NDC:
31722-627-26

Manufactured by Hetero Labs Limited.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91239
Status: Resolved
Manufacturer: Camber Pharmaceuticals, Inc
Sold By: pharmacies; hospitals
Manufactured In: United States, India
Distributed To: Nationwide

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 ยท 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.