Recall Enforment Report D-0156-2025
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by Amerisource Health Services LLC, originally initiated on 12-06-2024 for the product Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-05 The product was recalled due to cgmp deviations: presence of n-nitroso-duloxetine impurity above the recommended interim limit.. The product was distributed nationwide and the recall is currently ongoing.
Recall Enforcement Reports
| Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|---|
| D-0156-2025 | 12-06-2024 | 01-01-2025 | Class II | 13,678 bottles | Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-05 | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. | Ongoing |
| D-0157-2025 | 12-06-2024 | 01-01-2025 | Class II | 20,734 30-count bottles | Duloxetine Delayed-Release Capsules USP, 60 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-04 | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. | Ongoing |
| D-0155-2025 | 12-06-2024 | 01-01-2025 | Class II | 21,262 bottles | 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 | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. | Ongoing |
| D-0158-2025 | 12-06-2024 | 01-01-2025 | Class II | 1,815 bottles | Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08 | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. | Ongoing |
