RIFAMPIN Recall D-1343-2022
Description: Rifampin Capsules, USP, 150 mg, 30 count HDPE bottles, Rx Only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, 21202 NDC: 68180-658-06
RIFAMPIN Recall D-1343-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1343-2022 |
| Event ID | 90616 |
| Brand | RIFAMPIN |
| Generic Name | RIFAMPIN |
| Manufacturer | RIFAMPIN |
| Original Package? | 1 |
| Active Substance | RIFAMPIN |
| Drug Route | ORAL |
| Distribution | Product was distributed nationwide. |
| Quantity | 7,872/30 count bottles |
| Recall Reason | CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity. |
| Drug Classification | Class II |
| Drug Code Info | 20220824 |
| Product NDC | 68180-658 68180-659 |
| Product NUI | N0000175500 M0019113 |
| Drug UPC | 0368180658061 |
| Pharma Class (EPC) | Rifamycin Antibacterial [EPC] |
| Pharma Class (CS) | Rifamycins [CS] |
| Recall Initiation Date | 20220728 |
| Report Date | 20220824 |
| Classification Date | 20220816 |
| Address | Harborplace Tower111 S Calvert St Fl 21st Baltimore, MD 21202-6174 United States |
| Recalling Firm | Lupin Pharmaceuticals Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | VJT6J7R4TR |
| Drug Application Number | ANDA090034 |
| Structured Product Labeling (SPL ID) | d1ecd7ff-3a5a-46c6-9ca4-71156aa8fbb1 |
| Structured Product Labeling (SPL Set ID) | b56004f0-f23d-47f6-80c7-39884fccbccc |
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