The Recall Desk
LowFDA (Drugs)·D-0541-2018·Announced 2018-02-14

Teva Recalls Fentanyl Patches Due to Impurity Exceeding Limits

Teva Pharmaceuticals is recalling Fentanyl Transdermal Systems because a degradation product exceeded safety limits.

What this means for you

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 the rubric defines as unlikely to cause adverse health consequences, typically resulting in a score of 1 or 2.

Plain-English summary

Teva Pharmaceuticals USA is recalling Fentanyl Transdermal Systems, 50 mcg/h, packaged in 5 pouch system cartons. The recall involves approximately 929,916 units distributed nationwide within the United States.

The recall was initiated because the fentanyl-n-Oxide (FNO) degradant exceeded the established specification limits. This is a Class III recall, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.

Patients using these specific fentanyl patches should contact their healthcare provider for instructions on how to manage their pain and obtain replacement medication. The affected lots have expiration dates ranging from February 2018 to September 2019.

The recalled product

Product
Fentanyl Transdermal System, 50 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3212-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3212-54.
Manufacturer
Teva Pharmaceuticals USA
Category
Drug — Transdermal Patch
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 (20)

  • Lot #: 1103917A
  • Exp. Feb 2018
  • 1114192A
  • Exp. Apr 2018
  • 1125605A
  • Exp. Jun 2018
  • 1138897A
  • 1153171A
  • Exp. Aug 2018
  • 1156261A
  • Exp. Oct 2018
  • 1171595A
  • Exp. Nov 2018
  • 1179544A
  • Exp. Jan 2019
  • 1189531A
  • Exp. Mar 2019
  • 1211389A
  • Exp. May 2019
  • 1227468A

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Teva Pharmaceuticals USA 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 4 products in this recall →

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