D-0094-2023 Class III Terminated
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