FDA-Drug2024-12-11Class II
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
Amerisource Health Services LLC
Hazard
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Sold states
PA, OH, PR
Affected count
23,490 bottles
Manufactured in
2550 John Glenn Ave Ste A, Columbus, OH, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0100-2025Don't want to check this manually?
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