DOXYCYCLINE Recall D-1032-2022
Description: Doxycycline Capsules, USP, 100 mg, 50-count bottle, Rx only, Distributed by: Sun Pharmaceuticals, NDC 63304-616-50
DOXYCYCLINE Recall D-1032-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1032-2022 |
| Event ID | 89646 |
| Brand | DOXYCYCLINE |
| Generic Name | DOXYCYCLINE |
| Manufacturer | DOXYCYCLINE |
| Original Package? | 1 |
| Active Substance | DOXYCYCLINE |
| Drug Route | ORAL |
| Distribution | USA nationwide. |
| Quantity | 3 bottles |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 63304-614 63304-615 63304-616 |
| Product NUI | N0000175882 N0000007948 |
| Drug UPC | 0363304614015 |
| Pharma Class (EPC) | Tetracycline-class Drug [EPC] |
| Pharma Class (CS) | Tetracyclines [Chemical/Ingredient] |
| Recall Initiation Date | 20220413 |
| Report Date | 20220615 |
| Classification Date | 20220609 |
| Address | 9954 Maryland DriveDeep Run Iii Ste. 4000 Richmond, VA 23233 United States |
| Recalling Firm | Mckesson Medical-Surgical Inc. Corporate Office |
| Initial Notification | Letter |
| Unique Ingredient Identifier | N12000U13O |
| Drug Application Number | ANDA065053 |
| Structured Product Labeling (SPL ID) | d87fed49-4d26-4c1e-a097-7922f0f4d967 |
| Structured Product Labeling (SPL Set ID) | 829dbd3d-5c2b-47b8-96a5-423af78c93b9 |
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