LURASIDONE HYDROCHLORIDE Recall D-0267-2024
Description: Lurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-579-83.
LURASIDONE HYDROCHLORIDE Recall D-0267-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0267-2024 |
| Event ID | 93820 |
| Brand | LURASIDONE HYDROCHLORIDE |
| Generic Name | LURASIDONE HYDROCHLORIDE |
| Manufacturer | LURASIDONE HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | LURASIDONE HYDROCHLORIDE |
| Drug Route | ORAL |
| Distribution | Nationwide in the USA |
| Quantity | 9,408 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 | 47335-578 47335-684 47335-639 |
| 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 | O0P4I5851I |
| Drug Application Number | ANDA208066 |
| Structured Product Labeling (SPL ID) | 0d26f1ea-7eef-4d0a-9905-fd88daa35b65 |
| Structured Product Labeling (SPL Set ID) | 6d97d871-66d3-4ed8-bbc5-0620e9f69ae5 |
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