D-0486-2015 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- April 22, 2015
- Initiation Date
- April 14, 2015
- Termination Date
- January 20, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 78,522 Cartons
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.
Reason for Recall
Subpotent Drug: Flurandrenolide is subpotent.
Distribution Pattern
U.S. Nationwide, including Puerto Rico; United Kingdom.
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.