GABAPENTIN Recall D-0354-2023
Description: Gabapentin Tablets, USP 600 mg, 500 tablets per bottle, RX Only, Manufactured by ScieGen Pharmaceuticals Inc., Hauppauge, NY 11788, NDC: 50228-177-05.
GABAPENTIN Recall D-0354-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0354-2023 |
| Event ID | 91717 |
| Brand | GABAPENTIN |
| Generic Name | GABAPENTIN |
| Manufacturer | GABAPENTIN |
| Original Package? | 1 |
| Active Substance | GABAPENTIN |
| Drug Route | ORAL |
| Distribution | Nationwide in the USA and Puerto Rico |
| Quantity | 4,392 bottles |
| Recall Reason | Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles. |
| Drug Classification | Class III |
| Drug Code Info | 20230308 |
| Product NDC | 50228-177 50228-178 |
| Product NUI | N0000175753 N0000008486 |
| Drug UPC | 0350228179010 0350228179102 0350228180306 |
| Pharma Class (PE) | Decreased Central Nervous System Disorganized Electrical Activity [PE] |
| Pharma Class (EPC) | Anti-epileptic Agent [EPC] |
| Recall Initiation Date | 20230217 |
| Report Date | 20230308 |
| Classification Date | 20230227 |
| Address | 89 Arkay Dr Hauppauge, NY 11788-3727 United States |
| Recalling Firm | Sciegen Pharmaceuticals Inc |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 6CW7F3G59X |
| Drug Application Number | ANDA205101 |
| Structured Product Labeling (SPL ID) | f1dbd962-5c51-1a6e-e053-2a95a90a0553 |
| Structured Product Labeling (SPL Set ID) | 5ab9c18b-9568-4dcb-90b0-252aef8f8dc2 |
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