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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- 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, 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.
Product Codes/Lot Numbers:
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.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0543-2018
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