FDA recall D-0486-2015

Product

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

U.S. Nationwide, including Puerto Rico; United Kingdom.

Key facts

Status

Terminated

Initiation date

2015-04-14

Report date

2015-04-22

Termination date

2016-01-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Salt Lake City, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0486-2015