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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0094-2023 |
| Event ID | 91239 |
| Brand | LACOSAMIDE |
| Generic Name | LACOSAMIDE |
| Manufacturer | LACOSAMIDE |
| Original Package? | 1 |
| Active Substance | LACOSAMIDE |
| Drug Route | ORAL |
| Distribution | USA Nationwide |
| Recall Reason | Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content |
| Drug Classification | Class III |
| Drug Code Info | 20221221 |
| Product NDC | 31722-627 |
| Product NUI | N0000008486 |
| Drug UPC | 0331722627467 0331722627269 |
| Pharma Class (PE) | Decreased Central Nervous System Disorganized Electrical Activity [PE] |
| Recall Initiation Date | 20221206 |
| Report Date | 20221221 |
| Classification Date | 20221228 |
| Address | 1031 Centennial Ave Piscataway, NJ 08854-4125 United States |
| Recalling Firm | Camber Pharmaceuticals, Inc |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 563KS2PQY5 |
| Drug Application Number | ANDA209301 |
| 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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