Drug recall D-0053-2016

Class III Terminated reported Oct 28, 2015

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.

Lots and codes

Lot #: 107934 Exp 9/16, 108060 Exp 5/16

Recall details

Recalling firm
Rx PAK, Memphis, TN
Quantity
2530 bottles
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
October 13, 2015
Terminated
June 30, 2016

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