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
Reported: January 1, 2025 Initiated: December 6, 2024 #D-0157-2025
Product Description
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
Reason for Recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Details
- Recalling Firm
- Amerisource Health Services LLC
- Units Affected
- 20,734 30-count bottles
- Distribution
- Nationwide in the USA
- Location
- Columbus, OH
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Amerisource Health Services LLC. Units affected: 20,734 30-count bottles.
Why was this product recalled? ▼
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 1, 2025. Severity: Moderate. Recall number: D-0157-2025.
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