The Recall Desk
ModerateFDA (Drugs)·D-1436-2016·Announced 2016-07-20

Apotex Recalls Duloxetine Capsules Due to Dissolution Failure

Apotex Scientific is recalling Duloxetine Delayed-Release Capsules, 60 mg, because stability testing revealed out-of-specification dissolution results.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which indicates a remote possibility of adverse health consequences. The hazard is a quality control failure (dissolution) rather than a direct safety hazard like contamination or mislabeling of a common allergen, fitting the Moderate category for low-risk quality issues.

Plain-English summary

Apotex Scientific, Inc. is recalling Duloxetine Delayed-Release Capsules, USP, 60 mg, 30-count bottles. The recall involves approximately 605,989 bottles distributed nationwide, including Alaska, Hawaii, and Puerto Rico. The product is prescription-only and was manufactured by Apotex Inc. in Toronto, Ontario, for Apotex Corp. in Weston, Florida.

The recall was initiated because the product failed to meet dissolution specifications during stability testing. Dissolution is a critical quality attribute that ensures the medication releases the active ingredient at the intended rate. Out-of-specification results indicate that the product may not perform as expected.

Consumers and healthcare providers should stop using the affected lots and return them to the pharmacy or point of purchase for a refund or replacement. The affected lot numbers are KW2167, KY9960, KV9789, KV9788 (Exp 02/29/2016); KY9961 (Exp 04/30/2016); KX6311, KX6312, KY7795, KX6315 (Exp 05/31/2016); and KX6317 (Exp 06/30/2016).

The recalled product

Product
Duloxetine Delayed-Release Capsules, USP, 60 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2997-3; UPC # 360505299737;
Manufacturer
Apotex Scientific, Inc
Category
Drug — Antidepressant
Hazard

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 (14)

  • Lot #: KW2167
  • KY9960
  • KV9789
  • KV9788
  • Exp 02/29/2016
  • Lot #: KY9961
  • Exp 04/30/2016
  • Lot #: KX6311
  • KX6312
  • KY7795
  • KX6315
  • Exp 05/31/2016
  • Lot #: KX6317
  • Exp 06/30/2016.

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 →

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