Reported Dec 21, 2022 · Terminated

Lacosamide Oral Solution, USP, CV, 10mg/mL, packaged in 200 mL bottle, Rx Only, Manufactured for: Camber…

Camber Pharmaceuticals, Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

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: Camber Pharmaceuticals, Inc · 1031 Centennial Ave · Piscataway, NJ · 08854-4125

Is this the product you have?

  • Lacosamide Oral Solution, USP, CV, 10mg/mL, packaged in 200 mL bottle, Rx Only
  • Manufactured forCamber Pharmaceuticals, Inc., Piscataway, NJ 08854
  • Manufactured ByHETERO LABS LIMITED, Jeedimetla, Hyderabad - 500 055, India, NDC 31722-627-26
Lot codes and dates
    • Lot#: E222200
    • E222199
    • Exp 05/2024
    • E222228
    • Exp 06/2024
Amount recalled
N/A

Where it was sold

  • Nationwide

Why it was recalled

Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Mar 15, 2024 · Data as of Sep 19, 5:07 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.