Recall: D-0094-2023

Class III - Minor Violations

Class IIIClassification

2022-12-06Initiated

TerminatedStatus

Camber Pharmaceuticals, IncFirm

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

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

Distribution

USA Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.