PRAVASTATIN SODIUM Recall D-0424-2023
Description: Pravastatin Sodium Tablets USP, 80 mg, Rx Only, 90- count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729-011-15, UPC 3 16729 01115 0
PRAVASTATIN SODIUM Recall D-0424-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0424-2023 |
| Event ID | 91657 |
| Brand | PRAVASTATIN SODIUM |
| Generic Name | PRAVASTATIN SODIUM |
| Manufacturer | PRAVASTATIN SODIUM |
| Original Package? | 1 |
| Active Substance | PRAVASTATIN SODIUM |
| Drug Route | ORAL |
| Distribution | United States including Puerto Rico and Canada |
| Quantity | 1970 bottles |
| Recall Reason | CGMP Deviations: recalling drug products following an FDA inspection. |
| Drug Classification | Class II |
| Drug Code Info | 20230308 |
| Product NDC | 16729-008 16729-009 16729-010 |
| Drug UPC | 316729011150 |
| Recall Initiation Date | 20230207 |
| Report Date | 20230308 |
| Classification Date | 20230302 |
| Address | 1009 Slater Rd Ste 210B Durham, NC 27703-8446 United States |
| Recalling Firm | Accord Healthcare, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 3M8608UQ61 |
| Drug Application Number | ANDA207068 |
| Structured Product Labeling (SPL ID) | ed1b0412-f559-52cf-e053-2995a90acb3e |
| Structured Product Labeling (SPL Set ID) | 6c011348-a236-47d3-bbef-3e0b956dd080 |
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