FDA recall D-0094-2023

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

Reason for recall

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

Distribution

USA Nationwide

Key facts

Status

Terminated

Initiation date

2022-12-06

Report date

2022-12-21

Termination date

2024-03-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Piscataway, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0094-2023