Drug product
Fentanyl Transdermal System, 50 mcg/h, 1 system per pouch (NDC 0591-3212-54), packaged in 5-count systems per box (NDC 0591-3212-72), Rx only, Manufactured by Watson Laboratories, Inc, Corona, CA, 92880 USA; Distributed by: Watson Pharma, Inc.
D-599-2013
Product summary
- Firm
- Actavis
- Event
- Event 65334
- Status
- Terminated
- Classification
- Class III
- Quantity
- 98,952 boxes
- Official record key
drug-enforcement:D-599-2013
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot #: Patch 453658; Carton 453658A, Exp 09/13
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications