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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