Agency classClass IIIOur severity:Low FDA (Drugs)·D-1435-2016·Announced 2016-07-20

Apotex Recalls Duloxetine Capsules Due to Failed Dissolution Testing

Apotex Scientific is recalling specific lots of Duloxetine Delayed-Release Capsules because they failed dissolution specifications during stability testing.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which indicates a low risk of adverse health consequences. The issue is a failure in dissolution specifications during stability testing, which is a quality control issue rather than a direct safety hazard like contamination or mislabeling.

Plain-English summary

Apotex Scientific, Inc. is recalling Duloxetine Delayed-Release Capsules, USP, 20 mg, 60-count bottles. The affected product is prescription-only and was manufactured by Apotex Inc. in Toronto, Ontario, for Apotex Corp. in Weston, Florida. The recall covers specific lots with expiration dates of 04/30/2016.

The recall was initiated because the product failed to meet dissolution specifications during stability testing. Dissolution testing ensures that the medication releases the active ingredient at the correct rate; failing this specification means the product may not perform as intended.

The affected product was distributed nationwide, including Alaska, Hawaii, and Puerto Rico. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product is found, it should be returned to the pharmacy or supplier for a refund or replacement.

The recalled product

Product: Duloxetine Delayed-Release Capsules, USP, 20 mg, 60-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2995-6; UPC # 360505299560;
Manufacturer: Apotex Scientific, Inc
Category: Drug — Antidepressant
Hazard: failed-dissolution

Is your product affected?

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

Lot numbers (5)

Lot #: KV9795
KV9794
KV9796
KX6278
Exp 04/30/2016.

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Apotex Scientific, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Apotex Scientific, Inc

See all →

Moderate
Apotex Recalls Duloxetine Capsules Due to Dissolution Failure
FDA (Drugs) · 2016-07-20
Low
Apotex Recalls Duloxetine Capsules Due to Dissolution Failure
FDA (Drugs) · 2016-07-20

Same hazard · failed dissolution