FDAOctober 13, 2015drug

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, M...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

rx pak

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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