Lacosamide Solution
FDA Recall NDC 31722-627
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Lacosamide (NDC 31722-627). A significant event, classified as Class III, was initiated on Dec 06, 2022 by Camber Pharmaceuticals, Inc.. The reported reason for this action was: "Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content
Dec 06, 2022
Dec 21, 2022
N/A
Recall Profile & Regulatory Data
Event ID
91239
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Camber Pharmaceuticals, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Termination Date
Mar 15, 2024
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
Batch or Lot Expiration Information
Lot# : E222200, E222199, Exp 05/2024; E222228, Exp 06/2024
Affected Packages Involved in this Recall
31722-627-26Product
31722-627-46Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
