Status
Terminated
Drug Enforcement D-599-2013
Failed Impurities/Degradation Specifications
Classification
Class III
Report Date
June 19, 2013
Termination Date
April 9, 2014
Product Information
- 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.
- Product quantity
- 98,952 boxes
- Reason for recall
- Failed Impurities/Degradation Specifications
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Actavis
- Address
-
575/577/579 Chipeta Way, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-599-2013
- Event ID
- 65334
- Recall initiation date
- June 3, 2013
- Center classification date
- June 12, 2013
- Code info
- Lot #: Patch 453658; Carton 453658A, Exp 09/13
- More code info
- —