VERAPAMIL HYDROCHLORIDE Recall D-0592-2024
Description: Verapamil Hydrochloride Injection, USP 5 mg / 2mL(2.5 mg/mL), packaged as (a) 25x2 mL Single-Dose Vial per carton, Vial NDC: 70710-1643-1; Carton NDC 70710-1643-7; (b) 5x2 mL Single-Dose Vial per carton, Vial NDC: 70710-1643-1; Carton NDC 70710-1643-5; Rx Only, Manufactured by: Zydus Lifesciences Ltd. Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA)Inc., Pennington, NJ 08534,
VERAPAMIL HYDROCHLORIDE Recall D-0592-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0592-2024 |
| Event ID | 94912 |
| Brand | VERAPAMIL HYDROCHLORIDE |
| Generic Name | VERAPAMIL HYDROCHLORIDE |
| Manufacturer | VERAPAMIL HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | VERAPAMIL HYDROCHLORIDE |
| Drug Route | INTRAVENOUS |
| Distribution | Nationwide in the USA |
| Quantity | 170,755 vials |
| Recall Reason | Cross contamination with other products. |
| Drug Classification | Class III |
| Drug Code Info | 20240717 |
| Product NDC | 70710-1643 70710-1644 |
| Drug UPC | 0370710164379 0370710164355 |
| Recall Initiation Date | 20240702 |
| Report Date | 20240717 |
| Classification Date | 20240710 |
| Address | 73 Route 31 NN/A Pennington, NJ 08534-3601 United States |
| Recalling Firm | Zydus Pharmaceuticals (USA) Inc |
| Initial Notification | Letter |
| Unique Ingredient Identifier | V3888OEY5R |
| Drug Application Number | ANDA214215 |
| Structured Product Labeling (SPL ID) | ba7a1f8b-81a4-49ad-ae2c-2cd08a4ffffd |
| Structured Product Labeling (SPL Set ID) | c87c7f7e-cdf5-42c7-a831-a7515d2d51d6 |
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