December 2022 FDA Recall Lacosamide by Camber Pharmaceuticals, Inc
D-0094-2023 - Failed Excipient Specifications
This Class III drug recall was voluntarily initiated by Camber Pharmaceuticals, Inc on December 6, 2022 for the product Lacosamide. The FDA reported the reason for recall as failed excipient specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0094-2023
Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content
12-06-2022
12-21-2022
N/A
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Camber Pharmaceuticals, Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA Nationwide
03-15-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : E222200, E222199, Exp 05/2024; E222228, Exp 06/2024
