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.
Reported: June 19, 2013 Initiated: June 3, 2013 #D-599-2013
Product Description
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.
Reason for Recall
Failed Impurities/Degradation Specifications
Details
- Recalling Firm
- Actavis
- Units Affected
- 98,952 boxes
- Distribution
- Nationwide
- Location
- Salt Lake City, UT
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Actavis. Units affected: 98,952 boxes.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 19, 2013. Severity: Low. Recall number: D-599-2013.
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