DULOXETINE (DULOXETINE HYDROCHLORIDE)
Wed Jan 01 2025
1 of 14
Summary
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Product Description
| Drug | Manufacturer | Distribution Pattern | Number of Affected Units |
|---|---|---|---|
| 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 | BluePoint | Nationwide in the USA | 21,262 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 | BluePoint | Nationwide in the USA | 13,678 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 | BluePoint | Nationwide in the USA | 20,734 30-count 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 | BluePoint | Nationwide in the USA | 1,815 bottles |