OXCARBAZEPINE Recall D-0085-2023
Description: Oxcarbazepine Tablets 600mg, packaged in a) 100- count bottles (NDC 62756-185-88), b) 500-count bottles (NDC 62756-185-13), c)1000-count bottles (NDC 62756-185-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India.
OXCARBAZEPINE Recall D-0085-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0085-2023 |
| Event ID | 91311 |
| Brand | OXCARBAZEPINE |
| Generic Name | OXCARBAZEPINE |
| Manufacturer | OXCARBAZEPINE |
| Original Package? | 1 |
| Active Substance | OXCARBAZEPINE |
| Drug Route | ORAL |
| Distribution | Nationwide within the United States |
| Quantity | Lot HAC1474A: 4296 Bottles, Lot HAC1474B: 145 Bottles, Lot HAC1503A: 2124 Bottles |
| Recall Reason | Presence of foreign substance |
| Drug Classification | Class II |
| Drug Code Info | 20221228 |
| Product NDC | 62756-183 62756-184 62756-185 |
| Product NUI | N0000175753 N0000008486 |
| Drug UPC | 0362756183834 0362756185838 0362756184831 |
| Pharma Class (PE) | Decreased Central Nervous System Disorganized Electrical Activity [PE] |
| Pharma Class (EPC) | Anti-epileptic Agent [EPC] |
| Recall Initiation Date | 20221201 |
| Report Date | 20221228 |
| Classification Date | 20221219 |
| Address | 2 Independence Way Princeton, NJ 08540-6620 United States |
| Recalling Firm | SUN PHARMACEUTICAL INDUSTRIES INC |
| Unique Ingredient Identifier | VZI5B1W380 |
| Drug Application Number | ANDA077794 |
| Structured Product Labeling (SPL ID) | b631ee17-0686-46d5-ba72-0a346cf2bc24 |
| Structured Product Labeling (SPL Set ID) | 7ecd5eef-46f4-407f-9b63-ba65adb3eced |
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