Why it was recalled
Subpotent Drug: Flurandrenolide is subpotent.
Product description
Flurandrenolide Tape, USP, 4 mcg per sq cm, Rx Only. Distributed By: Actavis Pharma, Inc., Parsippany, NJ 07054, Manufactured By: 3M Company, St. Paul, MN, 55144. Labeled as A) Cordran Tape, Small Rolls, 24 in x 3 in, NDC: 52544-044-24, B) Cordran Tape, Large Rolls, 80 in x 3 in, NDC: 52544-044-80, C) Haelan Tape (Fludroxycortide), Bulk Rolls, NDC: 55515-014-00.
Lot numbers, UPCs & expiration codes
A) Lots: 266142A, 843021, 845760, 853846, 893193, 900634; Expiry: JAN-2016. B) Lots: 266142D, 822241, 853847, 862000, 874337, 893209; Expiry: JAN-2016. C) Lot: 266142C; Expiry: JAN-2016.
Where it was sold
U.S. Nationwide, including Puerto Rico; United Kingdom.
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-0486-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 14, 2015
- FDA report date
- Apr 22, 2015
- Quantity
- 78,522 Cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Actavis Laboratories
Original FDA data
Every field from FDA enforcement report D-0486-2015, exactly as published.
Show all FDA fields
- City
- Salt Lake City
- State
- UT
- Status
- Terminated
- Country
- United States
- Event ID
- 70987
- Address
- 577 S Chipeta Way
- Code information
- A) Lots: 266142A, 843021, 845760, 853846, 893193, 900634; Expiry: JAN-2016. B) Lots: 266142D, 822241, 853847, 862000, 874337, 893209; Expiry: JAN-2016. C) Lot: 266142C; Expiry: JAN-2016.
- Postal code
- 84108-1222
- Report date
- Apr 22, 2015
- Product type
- Drugs
- Recall number
- D-0486-2015
- Classification
- Class III
- Recalling firm
- Actavis Laboratories
- Product quantity
- 78,522 Cartons
- Termination date
- Jan 20, 2016
- Reason for recall
- Subpotent Drug: Flurandrenolide is subpotent.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Flurandrenolide Tape, USP, 4 mcg per sq cm, Rx Only. Distributed By: Actavis Pharma, Inc., Parsippany, NJ 07054, Manufactured By: 3M Company, St. Paul, MN, 55144. Labeled as A) Cordran Tape, Small Rolls, 24 in x 3 in, NDC: 52544-044-24, B) Cordran Tape, Large Rolls, 80 in x 3 in, NDC: 52544-044-80, C) Haelan Tape (Fludroxycortide), Bulk Rolls, NDC: 55515-014-00.
- Distribution pattern
- U.S. Nationwide, including Puerto Rico; United Kingdom.
- Recall initiation date
- Apr 14, 2015
- Initial firm notification
- Letter
- Center classification date
- Apr 15, 2015