FDAClass IIIDecember 21, 2022

Lacosamide Oral Solution recall

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

Why was Lacosamide Oral Solution recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
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
Recalling firm
Camber Pharmaceuticals, Inc
Quantity
N/A
Distribution
USA Nationwide
Recall date
December 21, 2022
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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