Direct Rx duloxetine 30 mg capsules exceed the interim nitrosamine limit

Plain-English summary

Duloxetine D/R, 30 mg, prescription only, packaged in 30-count (NDC 61919-0482-30), 60-count (NDC 61919-0482-60) and 90-count (NDC 61919-0482-90) bottles, packaged and distributed by Direct Rx and distributed by Breckenridge, is being recalled. The action covers 875 bottles.

The stated reason is CGMP deviations: the presence of a nitrosamine drug substance related impurity above the proposed interim limit. The FDA classified the action as Class II.

Affected lots include 15AU2420, 01JY2407 and 04OC2411 expiring 01/31/2027, and 12SE2418, 24OC2424 and 20NO2416, together with the further lots listed in the recall notice. Distribution was nationwide.

Patients holding affected lots should speak to their pharmacist or prescriber before stopping treatment, and pharmacies should follow the instructions issued by the distributor.

The recalled product

Product

Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-count bottle, NDC 61919-0482-60, c) 90-count bottle, NDC 61919-0482-90; Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037,

Manufacturer

Direct Rx

Category

Drug — Delayed-release capsule

Hazard

• nitrosamine
• impurity-limit
• cgmp-deviation
• class-ii

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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