Drug 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
D-0094-2023
Product summary
- Event
- Event 91239
- Status
- Terminated
- Classification
- Class III
- Quantity
- N/A
- Official record key
drug-enforcement:D-0094-2023
Official wording
Reason: Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content
Code information: Lot#: E222200, E222199, Exp 05/2024; E222228, Exp 06/2024
Distribution pattern: USA Nationwide
Derived failure modes
-
Potency or specification failure
out of specification