Sandoz Inc recalls Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 1 patch per pouch (NDC 66758-208-58), packaged in 4-count patc…

Recall date

February 2, 2017

Source

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

Recall number

D-0481-2017

FDA classification

Class II

Brand / firm

Sandoz Inc

Sold / distributed

Nationwide in the USA and Puerto Rico

Why it was recalled

Labeling: Incorrect Instructions:outer carton contains the incorrect instructions for Step 2 stating "Do cut the patch" rather than the correct instructions of "Do not cut the patch". The pouch containing the patch is labeled correctly.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 1 patch per pouch (NDC 66758-208-58), packaged in 4-count patches per carton (NDC 66758-208-54), Rx Only, Manufactured by ALZA Corporation, Vacaville, CA 95688 for Sandoz Inc., Princeton, NJ 08540.