Class II

Drug Recall: 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, In

Amerisource Health Services LLC · November 14, 2024

Reason for Recall

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit

Product Description

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

Distribution

PA, OH, PR

States Affected

OH, PA

Quantity Affected

23,490 bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0100-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.