FDAHealthJanuary 13, 2025

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b)

⚠️ CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: January 13, 2025

Nationwide within the United States

What's affected?

Product: Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (10x10 blister packs) NDC 0904-7043-61, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA.
Brand: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Lot code: a)

Additional details

Lot #: a) N01530, Exp. Date 01/2025; b) N01540, Exp. Date. 01/2025

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: a) 6408 boxes and b)1488 boxes.

View original FDA notice →

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