Teva Recalls Fentanyl Transdermal Systems Due to Impurity Levels
Teva Pharmaceuticals is recalling specific lots of Fentanyl Transdermal Systems because they contain a degradant called Fentanyl-n-Oxide that exceeds safety limits.
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 FDA classified this as a Class III recall, which indicates a low probability of adverse health consequences. The hazard involves a chemical impurity exceeding specifications, which fits the criteria for a moderate severity precautionary recall.
Plain-English summary
Teva Pharmaceuticals USA is recalling specific lots of Fentanyl Transdermal Systems, 75 mcg/h, packaged in 5 pouch systems. The recall is due to the presence of a degradant known as Fentanyl-n-Oxide (FNO) that exceeds established specification limits.
The affected product is distributed nationwide within the United States. The recall covers specific lot numbers with expiration dates ranging from March 2018 to August 2019. The product is manufactured by Actavis Laboratories UT, Inc. and distributed by Actavis Pharma, Inc.
Consumers and healthcare providers should check their inventory for the specific lot numbers listed in the recall notice. If the product matches the recalled lots, it should be returned to the pharmacy or distributor for replacement or refund.
The recalled product
- Product
- Fentanyl Transdermal System. 75 mcg/h, packaged in 5 pouch system (NDC 0591-3213-72), 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 0591-3213-54.
- 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 (11)
- Lot #: 1107745A
- Exp. Mar 2018
- 1122452A
- 1137109A
- Exp. Jun 2018
- 1144515A
- Exp. Oct 2018
- 1189477A
- Exp. Mar 2019
- 1215224A
- Exp. Aug 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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