Fentanyl Transdermal System. 75 mcg/h recall: Impurity Out of Spec
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.
Why was Fentanyl Transdermal System. 75 mcg/h recalled?
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 1107745A, Exp. Mar 2018;1122452A, 1137109A, Exp. Jun 2018; 1144515A, Exp. Oct 2018; 1189477A, Exp. Mar 2019; 1215224A, Exp. Aug 2019.
- 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.
- Recalling firm
- Teva Pharmaceuticals USA
- Quantity
- 576, 760 (5 pouches/carton)
- Distribution
- Distributed nationwide within the United States
- Recall date
- February 14, 2018
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)