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Class III: unlikely to cause harmTerminated

Camber Pharmaceuticals Lacosamide Oral Solution Recall

Lacosamide Oral Solution, USP, CV, 10mg/mL, packaged in 200 mL bottle, Rx Only, Manufac…

Camber Pharmaceuticals, Inc · Piscataway, NJ

Risk level
Class III
Reported by FDA
Dec 21, 2022
Recall ID
D-0094-2023
Check your lot numberHow we source this data

Summary

Camber Pharmaceuticals recalled Lacosamide Oral Solution starting Dec 6, 2022. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0094-2023 on Dec 21, 2022. Reason: Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content. Status: Terminated.

Why it was recalled

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

Product description

Lacosamide Oral Solution, USP, CV, 10mg/mL, packaged in 200 mL bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured By: HETERO LABS LIMITED, Jeedimetla, Hyderabad - 500 055, India, NDC 31722-627-26

Lot numbers, UPCs & expiration codes

Lot#: E222200, E222199, Exp 05/2024; E222228, Exp 06/2024

Where it was sold

USA Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0094-2023
Classification
Class III
Status
Terminated
Recall initiated
Dec 6, 2022
FDA report date
Dec 21, 2022
Quantity
N/A
Recall type
Voluntary: Firm initiated
Recalling firm
Camber Pharmaceuticals, Inc

Original FDA data

Every field from FDA enforcement report D-0094-2023, exactly as published.

Show all FDA fields
City
Piscataway
State
NJ
Status
Terminated
Country
United States
Event ID
91239
Address
1031 Centennial Ave
Code information
Lot#: E222200, E222199, Exp 05/2024; E222228, Exp 06/2024
Postal code
08854-4125
Report date
Dec 21, 2022
Product type
Drugs
Recall number
D-0094-2023
Classification
Class III
Recalling firm
Camber Pharmaceuticals, Inc
Termination date
Mar 15, 2024
Reason for recall
Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content
Voluntary / mandated
Voluntary: Firm initiated
Product description
Lacosamide Oral Solution, USP, CV, 10mg/mL, packaged in 200 mL bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured By: HETERO LABS LIMITED, Jeedimetla, Hyderabad - 500 055, India, NDC 31722-627-26
Distribution pattern
USA Nationwide
Recall initiation date
Dec 6, 2022
Initial firm notification
Letter
Center classification date
Dec 28, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0094-2023, published Dec 21, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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