VENLAFAXINE HYDROCHLORIDE Recall D-0310-2025
Description: Venlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only, Mfg. by: Zydus Lifesciences Ltd, Ahmedabad, India, Dist. by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-021-01.
VENLAFAXINE HYDROCHLORIDE Recall D-0310-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0310-2025 |
| Event ID | 96553 |
| Brand | VENLAFAXINE |
| Generic Name | VENLAFAXINE |
| Manufacturer | VENLAFAXINE |
| Original Package? | 1 |
| Active Substance | VENLAFAXINE HYDROCHLORIDE |
| Drug Route | ORAL |
| Distribution | US Nationwide. |
| Quantity | 13,128 100-Count Bottles |
| Recall Reason | Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet. |
| Drug Classification | Class II |
| Drug Code Info | 20250416 |
| Product NDC | 68382-018 68382-019 68382-020 |
| Drug UPC | 0368382019011 0368382018014 0368382021014 |
| Recall Initiation Date | 20250321 |
| Report Date | 20250416 |
| Classification Date | 20250404 |
| Address | 73 Route 31 NN/A Pennington, NJ 08534-3601 United States |
| Recalling Firm | Zydus Pharmaceuticals (USA) Inc |
| Initial Notification | |
| Unique Ingredient Identifier | 7D7RX5A8MO |
| Drug Application Number | ANDA077653 |
| Structured Product Labeling (SPL ID) | ea404f6c-7e07-4779-a52c-8cffb92718ef |
| Structured Product Labeling (SPL Set ID) | 72efad5f-0909-46a5-aa13-ac24fe015fe6 |
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