Agency classClass IIIOur severity:Low FDA (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.

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 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: impurity

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 →

Same manufacturer · Teva Pharmaceuticals USA

See all →

Moderate
Doxylamine Succinate and Pyridoxine Hydrochloride Tablets Recalled for Failed Dissolution
FDA (Drugs) · 2022-02-09
Low
Prescription Drug Recall: Mimvey Mislabeling by Teva Pharmaceuticals
FDA (Drugs) · 2022-02-09
Moderate
Tretinoin Capsules 10 mg Recalled for Failed Dissolution Specifications
FDA (Drugs) · 2022-02-09
Low
Mimvey Estradiol/Norethindrone Prescription Drug Mislabeling Recall
FDA (Drugs) · 2022-02-09
Moderate
Brinzolamide Ophthalmic Suspension recalled for defective container caps
FDA (Drugs) · 2022-01-26

Same hazard · impurity