Product Safety Recalls

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LACOSAMIDE Recall D-0094-2023

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

LACOSAMIDE Recall D-0094-2023 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-0094-2023
Event ID91239
Original Package?1
Active SubstanceLACOSAMIDE
Drug RouteORAL
DistributionUSA Nationwide
Recall ReasonFailed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content
Drug ClassificationClass III
Drug Code Info20221221
Product NDC31722-627
Product NUIN0000008486
Drug UPC0331722627467 0331722627269
Pharma Class (PE)Decreased Central Nervous System Disorganized Electrical Activity [PE]
Recall Initiation Date20221206
Report Date20221221
Classification Date20221228
Address1031 Centennial Ave
Piscataway, NJ 08854-4125
United States
Recalling FirmCamber Pharmaceuticals, Inc
Initial Notification Letter
Unique Ingredient Identifier563KS2PQY5
Drug Application NumberANDA209301
Structured Product Labeling (SPL ID)eeabafb5-f74e-755e-e053-2995a90a52e5
Structured Product Labeling (SPL Set ID)bbd80370-3d23-41f8-8914-c6ea897c0154
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