Recalls / Class III
Class IIID-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
- Brand name
- Lacosamide
- Generic name
- Lacosamide
- Active ingredient
- Lacosamide
- Route
- Oral
- NDC
- 31722-627
- FDA application
- ANDA209301
- Affected lot / code info
- Lot#: E222200, E222199, Exp 05/2024; E222228, Exp 06/2024
Why it was recalled
Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content
Recalling firm
- Firm
- Camber Pharmaceuticals, Inc
- Manufacturer
- Camber Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1031 Centennial Ave, N/A, Piscataway, New Jersey 08854-4125
Distribution
- Quantity
- N/A
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2022-12-06
- FDA classified
- 2022-12-28
- Posted by FDA
- 2022-12-21
- Terminated
- 2024-03-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0094-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.