Class III
Terminated
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
- Company
- Rx Pak
- Recall Initiated
- October 13, 2015
- Posted
- October 28, 2015
- Recall Number
- D-0053-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2530 bottles
- Firm Location
- Memphis, TN, United States
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
Lot / Code Info
Lot #: 107934 Exp 9/16, 108060 Exp 5/16
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