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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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, Exp. Jun 2019; 1231784A, 1232943A, Exp. Sep 2019.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Teva Pharmaceuticals USA
- Reason for Recall:
- Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
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, Exp. Jun 2019; 1231784A, 1232943A, Exp. Sep 2019.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0541-2018
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