Class 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
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
- Recall number
- D-0100-2025
- Report date
- December 11, 2024
- Classification
- Class II
- Status in dataset
- Ongoing
- Recalling firm
- Amerisource Health Services LLC
- Generic names
- Not provided
- Brand names
- Not provided
- Product NDCs
- Not provided
Code and lot information
a) 30 count; Lot, expiry: DT3023019B, DT3023020A, exp 01/31/2025 b) 1000 count; Lot, expiry: DTB23098A, exp 08/31/2025
Distribution
PA, OH, PR
Do not stop or change a prescribed medication based only on this page.Contact your pharmacist or prescriber and compare the exact product, manufacturer, NDC, and lot information.
Source and limitations
This page reflects a public openFDA Drug Enforcement record. The dataset was last checked on September 23, 2026. openFDA states that enforcement data should not be used alone to issue public alerts or track the full lifecycle of a recall.
Review the official FDA Drug Recalls page and the underlying openFDA query.