FDA recall D-0053-2016

Rx PAK · Class III · drug

Product

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

Reason for recall

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

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2015-10-13
Report date: 2015-10-28
Termination date: 2016-06-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: Memphis, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0053-2016