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Recall Observatory FDA recall evidence

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

October 13, 2015

Class III

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

    reason.no_named_rule · v1.0.0

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