CINACALCET HYDROCHLORIDE Recall D-0263-2024
Description: Cinacalcet Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191 (U.T. of D & NH), India, NDC 47335-380-83.
CINACALCET HYDROCHLORIDE Recall D-0263-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0263-2024 |
| Event ID | 93820 |
| Brand | CINACALCET |
| Generic Name | CINACALCET |
| Manufacturer | CINACALCET |
| Original Package? | 1 |
| Active Substance | CINACALCET HYDROCHLORIDE |
| Drug Route | ORAL |
| Distribution | Nationwide in the USA |
| Quantity | 1,728 bottles |
| Recall Reason | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. |
| Drug Classification | Class II |
| Drug Code Info | 20240131 |
| Product NDC | 47335-379 47335-380 47335-600 |
| Drug UPC | 0347335600834 |
| Recall Initiation Date | 20240118 |
| Report Date | 20240131 |
| Classification Date | 20240125 |
| Address | 2 Independence Way Princeton, NJ 08540-6620 United States |
| Recalling Firm | SUN PHARMACEUTICAL INDUSTRIES INC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 1K860WSG25 |
| Drug Application Number | ANDA207008 |
| Structured Product Labeling (SPL ID) | fb601aec-aba6-4bec-a98d-51e556fef95c |
| Structured Product Labeling (SPL Set ID) | 092553cf-1bcd-4c19-9adf-b46f2bda5c9e |
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