DULOXETINE HYDROCHLORIDE Recall D-0100-2025
Description: Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories
DULOXETINE HYDROCHLORIDE Recall D-0100-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0100-2025 |
| Event ID | 95849 |
| Brand | DULOXETINE |
| Generic Name | DULOXETINE HYDROCHLORIDE |
| Manufacturer | DULOXETINE HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | DULOXETINE HYDROCHLORIDE |
| Drug Route | ORAL |
| Distribution | PA, OH, PR |
| Quantity | 23,490 bottles |
| Recall Reason | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit |
| Drug Classification | Class II |
| Drug Code Info | 20241211 |
| Product NDC | 68001-413 68001-414 68001-415 |
| Drug UPC | 0368001413060 0368001415040 0368001414043 |
| Recall Initiation Date | 20241114 |
| Report Date | 20241211 |
| Classification Date | 20241203 |
| Address | 2550 John Glenn Ave Ste A Columbus, OH 43217-1188 United States |
| Recalling Firm | Amerisource Health Services LLC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 9044SC542W |
| Drug Application Number | ANDA090778 |
| Structured Product Labeling (SPL ID) | 1a275613-8b5c-f2f7-e063-6294a90ac153 |
| Structured Product Labeling (SPL Set ID) | c9492555-6061-47bf-923e-26d4d5528453 |
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