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Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle, Manufactured by: Au...

FDA Recall #D-0101-2025 — Class II — November 14, 2024

Recall #D-0101-2025 Date: November 14, 2024 Classification: Class II Status: Ongoing

Product Description

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

Reason for Recall

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

Recalling Firm

Amerisource Health Services LLC — Columbus, OH

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

8,561 bottles

Distribution

PA, OH, PR

Code Information

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

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