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
D-0053-2016
Product summary
- Firm
- Rx PAK
- Event
- Event 72457
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2530 bottles
- Official record key
drug-enforcement:D-0053-2016
Official wording
Reason: Labeling: Not elsewhere classified - Product label incorrectly lists Scopolamine Hydrocodone as an active ingredient on the side panel instead of Scopolamine Hydrobromide.
Code information: Lot #: 107934 Exp 9/16, 108060 Exp 5/16
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Labeling: Not elsewhere classified - Product label incorrectly lists Scopolamine Hydrocodone as an active ingredient on the side panel instead of Scopolamine Hydrobromide.