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

FDA Recall #D-0094-2023 — Class III — December 6, 2022

Recall #D-0094-2023 Date: December 6, 2022 Classification: Class III Status: Terminated

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

Reason for Recall

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

Recalling Firm

Camber Pharmaceuticals, Inc — Piscataway, NJ

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

N/A

Distribution

USA Nationwide

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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