Teva Recalls Fentanyl Transdermal Systems Due to Impurity Exceeding Limits
Teva Pharmaceuticals is recalling specific lots of 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 FDA classifies this recall as Class III, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or minor specification issues.
Plain-English summary
Teva Pharmaceuticals USA is recalling specific lots of Fentanyl Transdermal Systems, 100 mcg/h, packaged in 5 pouch systems. The recall is due to the presence of a degradation product called Fentanyl-n-Oxide (FNO) that exceeded established specification limits.
The affected product is a prescription-only medication manufactured by Actavis Laboratories UT, Inc. and distributed by Actavis Pharma, Inc. The recall covers specific lot numbers with expiration dates ranging from February 2018 to June 2019. The product was distributed nationwide within the United States.
Consumers and healthcare providers should stop using the affected lots and contact their healthcare provider or pharmacist for guidance on alternative treatment options. The FDA classifies this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
The recalled product
- Product
- Fentanyl Transdermal System, 100 mcg/h, packaged in 5 pouch system (NDC 0591-3214-72), 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 0591-3214-54.
- 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 (14)
- Lot #: 1096857A
- Exp. Feb 2018
- 1115872A
- Exp. Apr 2018
- 1123625A
- Exp. May 2018
- 1148775A. 1157255A
- Exp. Aug 2018
- 1169928A
- Exp. Nov 2018
- 1196300A
- Exp. Apr 2019
- 1213533A
- Exp. Jun 2019.
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.
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