Actavis Laboratories recalls Flurandrenolide Tape, USP, 4 mcg per sq cm, Rx Only. Distributed By: Actavis Pharma, Inc., Parsippany, NJ 07054, Manufa…

Recall date

April 14, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0486-2015

FDA classification

Class III

Brand / firm

Actavis Laboratories

Sold / distributed

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

Why it was recalled

Subpotent Drug: Flurandrenolide is subpotent.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.