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.
Reported: October 3, 2012 Initiated: July 11, 2012 #D-1693-2012
Product Description
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.
Reason for Recall
Subpotent; some patches may not contain fentanyl gel
Details
- Recalling Firm
- Actavis
- Units Affected
- 98,088 cartons (5 pouches per carton)
- Distribution
- Nationwide
- Location
- Salt Lake City, UT
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Actavis. Units affected: 98,088 cartons (5 pouches per carton).
Why was this product recalled? ▼
Subpotent; some patches may not contain fentanyl gel
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 3, 2012. Severity: Moderate. Recall number: D-1693-2012.
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