FDAClass IIIApril 22, 2015

Flurandrenolide Tape recall: Subpotent

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.

Why was Flurandrenolide Tape recalled?

Subpotent Drug: Flurandrenolide is subpotent.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

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.
Recalling firm
Actavis Laboratories
Quantity
78,522 Cartons
Distribution
U.S. Nationwide, including Puerto Rico; United Kingdom.
Recall date
April 22, 2015
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls