POSACONAZOLE Recall D-0268-2023
Description: Posaconazole Delayed-Release Tablets, 100 mg, 60-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009; Manufactured by: Biocon Pharma Limited, Bengaluru, India - 560 099, NDC 70377-038-11.
POSACONAZOLE Recall D-0268-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0268-2023 |
| Event ID | 91577 |
| Brand | POSACONAZOLE |
| Generic Name | POSACONAZOLE |
| Manufacturer | POSACONAZOLE |
| Original Package? | 1 |
| Active Substance | POSACONAZOLE |
| Drug Route | ORAL |
| Distribution | Nationwide in the USA |
| Quantity | 3665 bottles |
| Recall Reason | Failed Impurities/Degradation Specifications: High Out Of Specification degradation results. |
| Drug Classification | Class II |
| Drug Code Info | 20230215 |
| Product NDC | 70377-038 |
| Product NUI | N0000175487 M0002083 |
| Pharma Class (EPC) | Azole Antifungal [EPC] |
| Pharma Class (CS) | Azoles [CS] |
| Recall Initiation Date | 20230131 |
| Report Date | 20230215 |
| Classification Date | 20230214 |
| Address | 485 HWY 1 (S) ISELIN, NJ 08830 United States |
| Recalling Firm | BIOCON PHARMA INC |
| Initial Notification | |
| Unique Ingredient Identifier | 6TK1G07BHZ |
| Drug Application Number | ANDA214476 |
| Structured Product Labeling (SPL ID) | b7a2fd29-83b5-6ae6-775c-98f91a6c0ea4 |
| Structured Product Labeling (SPL Set ID) | e0e8023a-3c82-e455-a57b-ccc0206ad156 |
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