DOXYCYCLINE Recall D-0178-2024
Description: Doxycycline Capsules, USP 100 mg, 50 Capsules, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 Unite States; Manufactured by: Lupin Limited, Nagpur - 441 108, INDIA. NDC 68180-652-08
DOXYCYCLINE Recall D-0178-2024 Information
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0178-2024 |
| Event ID | 89450 |
| Brand | DOXYCYCLINE |
| Generic Name | DOXYCYCLINE |
| Manufacturer | DOXYCYCLINE |
| Original Package? | 1 |
| Active Substance | DOXYCYCLINE |
| Drug Route | ORAL |
| Distribution | Nationwide USA |
| Quantity | 1 unit |
| Recall Reason | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. |
| Drug Classification | Class II |
| Drug Code Info | 20240103 |
| Product NDC | 68180-650 68180-651 68180-652 |
| Product NUI | N0000175882 N0000007948 |
| Drug UPC | 0368180652083 0368180650010 |
| Pharma Class (EPC) | Tetracycline-class Drug [EPC] |
| Pharma Class (CS) | Tetracyclines [Chemical/Ingredient] |
| Recall Initiation Date | 20220126 |
| Report Date | 20240103 |
| Classification Date | 20231226 |
| Address | 7200 Cardinal Pl W Dublin, OH 43017-1094 United States |
| Recalling Firm | CARDINAL HEALTHCARE |
| Initial Notification | Letter |
| Unique Ingredient Identifier | N12000U13O |
| Drug Application Number | ANDA204234 |
| Structured Product Labeling (SPL ID) | 16f7a4ab-b0e6-4429-b586-fb5e9dd7314a |
| Structured Product Labeling (SPL Set ID) | bcc65910-30d8-4807-ab61-607a56382924 |
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