ATORVASTATIN CALCIUM TRIHYDRATE Recall D-0726-2022
Description: Atorvstatin Calcium Tablets, USP 80 mg*, 90 Tablets, Rx Only, Mrd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409, INDIA, NDC 55111-124-90
ATORVASTATIN CALCIUM TRIHYDRATE Recall D-0726-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0726-2022 |
| Event ID | 89833 |
| Brand | ATORVASTATIN CALCIUM |
| Generic Name | ATORVASTATIN CALCIUM |
| Manufacturer | ATORVASTATIN CALCIUM |
| Original Package? | 1 |
| Active Substance | ATORVASTATIN CALCIUM TRIHYDRATE |
| Drug Route | ORAL |
| Distribution | Nationwide in the USA. |
| Quantity | 28,068 bottles |
| Recall Reason | Failed Impurities/Degradation Specifications: Out of Specification results for related substance. |
| Drug Classification | Class III |
| Drug Code Info | 20220406 |
| Product NDC | 55111-124 |
| Recall Initiation Date | 20220316 |
| Report Date | 20220406 |
| Classification Date | 20220329 |
| Address | 107 College Rd E Princeton, NJ 08540-6623 United States |
| Recalling Firm | Dr. Reddy's Laboratories, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 48A5M73Z4Q |
| Drug Application Number | ANDA202357 |
| Structured Product Labeling (SPL ID) | 3ec2bef7-b820-857f-1c70-e57c2d2c6dbf |
| Structured Product Labeling (SPL Set ID) | 6ccdb6f3-22c7-5b48-46bc-ce4a4c65eb4d |
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