FDAFDA · Food and drugs·Recall number D-0094-2023
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
Published December 21, 2022 · Recall initiated: December 6, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- LACOSAMIDE
- Manufacturer
- Camber Pharmaceuticals, Inc
- Distributor
- USA Nationwide
- UPC
- 0331722627269
- Lot
- Lot#: E222200, E222199, Exp 05/2024; E222228, Exp 06/2024
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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