D-0053-2016 Class III Terminated
FDA drug recall D-0053-2016 was initiated by Rx PAK on October 13, 2015 and is designated Class III. 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. The recall status is terminated (terminated June 30, 2016). Affected quantity: 2530 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- October 28, 2015
- Initiation Date
- October 13, 2015
- Termination Date
- June 30, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2530 bottles
Product Description
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 Pattern
Nationwide
Code Information
Lot #: 107934 Exp 9/16, 108060 Exp 5/16