Why it was recalled
Failed Impurities/Degradation Specifications
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.
Lot numbers, UPCs & expiration codes
Lot #: Patch 453658; Carton 453658A, Exp 09/13
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-599-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 3, 2013
- FDA report date
- Jun 19, 2013
- Quantity
- 98,952 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Actavis
Original FDA data
Every field from FDA enforcement report D-599-2013, exactly as published.
Show all FDA fields
- City
- Salt Lake City
- State
- UT
- Status
- Terminated
- Country
- United States
- Event ID
- 65334
- Address
- 575/577/579 Chipeta Way
- Code information
- Lot #: Patch 453658; Carton 453658A, Exp 09/13
- Postal code
- 84108-1222
- Report date
- Jun 19, 2013
- Product type
- Drugs
- Recall number
- D-599-2013
- Classification
- Class III
- Recalling firm
- Actavis
- Product quantity
- 98,952 boxes
- Termination date
- Apr 9, 2014
- Reason for recall
- Failed Impurities/Degradation Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 3, 2013
- Initial firm notification
- Letter
- Center classification date
- Jun 12, 2013