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

Recall Number: D-0094-2023

Firm: Camber Pharmaceuticals, Inc

Classification: Class III

Status: Terminated

Report Date: 20221221

Initiation Date: 20221206

Termination Date: 20240315

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

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