The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-1437-2016·Announced 2016-07-20

Apotex Recalls Duloxetine Capsules Due to Dissolution Failure

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

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 recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or minor quality issues.

Plain-English summary

Apotex Scientific, Inc. is recalling Duloxetine Delayed-Release Capsules, USP, 30 mg, 30-count bottles. The recall involves specific lots (KY5120, KW2164, KY9953, KV9791, KV9792) with an expiration date of 03/31/2016. The product was distributed nationwide, including Alaska, Hawaii, and Puerto Rico.

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 correct rate for the body to absorb it properly. Out-of-specification results indicate that the product may not perform as intended.

Consumers and healthcare providers should stop using the affected bottles and return them to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.

The recalled product

Product
Duloxetine Delayed-Release Capsules, USP, 30 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2996-3; UPC # 360505299638.
Manufacturer
Apotex Scientific, Inc
Category
Drug — Prescription Medication
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 (6)

  • Lot #: KY5120
  • KW2164
  • KY9953
  • KV9791
  • KV9792
  • Exp 03/31/2016.

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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