ZILEUTON Recall D-1150-2022
Description: Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 by Lupin Limited, Nagpur-441108, India, NDC 68180-169-16
ZILEUTON Recall D-1150-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1150-2022 |
| Event ID | 90415 |
| Brand | ZILEUTON |
| Generic Name | ZILEUTON |
| Manufacturer | ZILEUTON |
| Original Package? | 1 |
| Active Substance | ZILEUTON |
| Drug Route | ORAL |
| Distribution | Product was distributed to 10 wholesalers/distributors and one mail order account who may have further distributed the product nationwide. |
| Quantity | 3,216 bottles |
| Recall Reason | Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study. |
| Drug Classification | Class II |
| Drug Code Info | 20220622 |
| Product NDC | 68180-169 |
| Product NUI | N0000175956 N0000175955 N0000008683 |
| Pharma Class (PE) | Decreased Leukotriene Production [PE] |
| Pharma Class (EPC) | 5-Lipoxygenase Inhibitor [EPC] |
| Recall Initiation Date | 20220610 |
| Report Date | 20220622 |
| Classification Date | 20220615 |
| 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 | V1L22WVE2S |
| Drug Application Number | ANDA211972 |
| Structured Product Labeling (SPL ID) | 5ccc51b9-399b-4c7e-b2e4-1bde256a0aee |
| Structured Product Labeling (SPL Set ID) | cf392f79-2276-4fe1-8fa8-74afd5150f73 |
| Similar To |