CINACALCET HYDROCHLORIDE Recall D-0078-2025
Description: Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPE bottle (NDC 65862-832-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
CINACALCET HYDROCHLORIDE Recall D-0078-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0078-2025 |
| Event ID | 95730 |
| Brand | CINACALCET |
| Generic Name | CINACALCET |
| Manufacturer | CINACALCET |
| Original Package? | 1 |
| Active Substance | CINACALCET HYDROCHLORIDE |
| Drug Route | ORAL |
| Distribution | USA Nationwide |
| Quantity | 3336 bottles |
| Recall Reason | cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit |
| Drug Classification | Class II |
| Drug Code Info | 20241211 |
| Product NDC | 65862-831 65862-832 65862-833 |
| Recall Initiation Date | 20241107 |
| Report Date | 20241211 |
| Classification Date | 20241129 |
| Address | 279 Princeton Hightstown Rd East Windsor, NJ 08520-1401 United States |
| Recalling Firm | Aurobindo Pharma USA Inc |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 1K860WSG25 |
| Drug Application Number | ANDA206125 |
| Structured Product Labeling (SPL ID) | 5aadf0b6-2c49-48d4-8d22-2fbf99dbf4e6 |
| Structured Product Labeling (SPL Set ID) | 42e99112-c402-4662-877f-9e3a84dff9f2 |
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