D-0094-2023 Class III Terminated

Recalled by Camber Pharmaceuticals, Inc — Piscataway, NJ

Recall Details

Product Type
Drugs
Report Date
December 21, 2022
Initiation Date
December 6, 2022
Termination Date
March 15, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

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

Distribution Pattern

USA Nationwide

Code Information

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