Why it was recalled
Subpotent; some patches may not contain fentanyl gel
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.
Lot numbers, UPCs & expiration codes
Lot number 455040A (carton) 455040 (pouch)
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-1693-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 11, 2012
- FDA report date
- Oct 3, 2012
- Quantity
- 98,088 cartons (5 pouches per carton)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Actavis
Original FDA data
Every field from FDA enforcement report D-1693-2012, exactly as published.
Show all FDA fields
- City
- Salt Lake City
- State
- UT
- Status
- Terminated
- Country
- United States
- Event ID
- 62384
- Address
- 575/577/579 Chipeta Way
- Code information
- Lot number 455040A (carton) 455040 (pouch)
- Postal code
- 84108-1222
- Report date
- Oct 3, 2012
- Product type
- Drugs
- Recall number
- D-1693-2012
- Classification
- Class II
- Recalling firm
- Actavis
- Product quantity
- 98,088 cartons (5 pouches per carton)
- Termination date
- Apr 10, 2013
- Reason for recall
- Subpotent; some patches may not contain fentanyl gel
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 11, 2012
- Initial firm notification
- Letter
- Center classification date
- Sep 25, 2012