Rx PAK recalls Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) tablets, 100-count bottle, Rx…

Recall date

October 13, 2015

Source

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

Recall number

D-0053-2016

FDA classification

Class III

Brand / firm

Rx PAK

Sold / distributed

Nationwide

Why it was recalled

Labeling: Not elsewhere classified - Product label incorrectly lists Scopolamine Hydrocodone as an active ingredient on the side panel instead of Scopolamine Hydrobromide.

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

What was recalled

Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) tablets, 100-count bottle, Rx only, Manufactured for Concordia Pharmaceuticals, Inc., St. Michael, Barbados BB11005, Manufactured by IriSys, LLC San Diego, CA 92121, Repackaged by: RxPak, Div. of McKesson, Memphis, TN 38141, NDC 59212-425-10