FDAHealthNovember 14, 2024

Amerisource Health Services LLC — Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Labor

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

Is this relevant to me?

Geography: PA, OH, PR
Source agency: FDA
Category: Health
Published: November 14, 2024

PA, OH, PR

What's affected?

Product: 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
Brand: Amerisource Health Services LLC
Lot code: DT6023034A

Additional details

Lot, expiry: DT6022159A, DT6022167A, DT6022168A, exp 11/30/2024; Lot DT6023034A, 12/31/2024; Lots DT6023050A, DT6023051A, DT6023063A, DT6023067A, exp 01/31/2025; Lots DT6023073A, DT6023072A, exp 02/28/2025

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 8,561 bottles.

View original FDA notice →

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