Drug product
Fentanyl Transdermal System, 100 mcg/h, each transdermal system contains: 10 mg fentanyl and 0.4 mL alcohol USP, Rx only, supplied in single pouches (NDC 0591-3214-54 (pouch)), 5 pouches per carton (NDC 0591-3214-72 (Carton)), Manufactured by Watson laboratories Inc., Corona, CA, Distributed by: Watson, Pharma Inc.
D-1693-2012
Product summary
- Firm
- Actavis
- Event
- Event 62384
- Status
- Terminated
- Classification
- Class II
- Quantity
- 98,088 cartons (5 pouches per carton)
- Official record key
drug-enforcement:D-1693-2012
Official wording
Reason: Subpotent; some patches may not contain fentanyl gel
Code information: Lot number 455040A (carton) 455040 (pouch)
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Subpotent