DULOXETINE HYDROCHLORIDE Recall D-0155-2025
Description: Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-04
DULOXETINE HYDROCHLORIDE Recall D-0155-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0155-2025 |
| Event ID | 95953 |
| Brand | DULOXETINE |
| Generic Name | DULOXETINE HYDROCHLORIDE |
| Manufacturer | DULOXETINE HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | DULOXETINE HYDROCHLORIDE |
| Drug Route | ORAL |
| Distribution | Nationwide in the USA |
| Quantity | 21,262 bottles |
| Recall Reason | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. |
| Drug Classification | Class II |
| Drug Code Info | 20250101 |
| Product NDC | 68001-413 68001-414 68001-415 |
| Drug UPC | 0368001413060 0368001415040 0368001414043 |
| Recall Initiation Date | 20241206 |
| Report Date | 20250101 |
| Classification Date | 20241223 |
| 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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