SERTRALINE HYDROCHLORIDE Recall D-0205-2024
Description: Sertraline Tablets, USP 100 mg, 30 tablets per bottle, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Cipla USA, Inc., Warren, NJ 07059, Packaged by: Legacy Pharmaceutical Packaging LLC., Earth City, MO 63045, NDC# 68645-523-54
SERTRALINE HYDROCHLORIDE Recall D-0205-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0205-2024 |
| Event ID | 93605 |
| Brand | SERTRALINE HYDROCHLORIDE |
| Generic Name | SERTRALINE HYDROCHLORIDE |
| Manufacturer | SERTRALINE HYDROCHLORIDE |
| Active Substance | SERTRALINE HYDROCHLORIDE |
| Drug Route | ORAL |
| Distribution | CA and AR |
| Quantity | 161,664 bottles |
| Recall Reason | CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product. |
| Drug Classification | Class II |
| Drug Code Info | 20240103 |
| Product NDC | 68645-521 68645-522 68645-523 |
| Drug UPC | 0368645522548 0368645521541 0368645523545 |
| Recall Initiation Date | 20231211 |
| Report Date | 20240103 |
| Classification Date | 20231226 |
| Address | 13333 Lakefront Dr Earth City, MO 63045-1514 United States |
| Recalling Firm | Legacy Pharmaceutical Packaging LLC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | UTI8907Y6X |
| Drug Application Number | ANDA077397 |
| Structured Product Labeling (SPL ID) | 0c6a56f2-3201-f4b8-e063-6394a90a788f |
| Structured Product Labeling (SPL Set ID) | bd86b293-dab9-4d37-95eb-2bffca335d16 |
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