D-0543-2018 Class III Terminated
FDA drug recall D-0543-2018 was initiated by Teva Pharmaceuticals USA on Jan 29, 2018 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits The recall status is terminated (terminated Sep 5, 2018). Affected quantity: 554, 562 (5 pouches/carton).
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 14, 2018
- Initiation Date
- Jan 29, 2018
- Termination Date
- Sep 5, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 554, 562 (5 pouches/carton)
Product 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.
Reason for Recall
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Distribution Pattern
Distributed nationwide within the United States
Code Information
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.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0543-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026