DULOXETINE (DULOXETINE HYDROCHLORIDE)
Wed Dec 11 2024
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, 60 mg, Rx only, 1,000 count bottle, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08 | BluePoint | PA, OH, PR | 8,561 bottles |
| 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 | BluePoint | PA, OH, PR | 23,490 bottles |
| Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-413-06 | BluePoint | PA, OH, PR | 37,916 bottles |