Reported Oct 28, 2015 · Terminated
Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) tablets, 100-count bottle, Rx…
Rx PAK
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Rx PAK · 4971 Southridge Blvd Ste 111-115 · Memphis, TN · 38141-8300
Is this the product you have?
- 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 byRxPak, Div. of McKesson, Memphis, TN 38141, NDC 59212-425-10
- Lot codes and dates
Lot #: 107934 Exp 9/16108060 Exp 5/16
- Amount recalled
- 2530 bottles
Where it was sold
- Nationwide
Why it was recalled
Labeling: Not elsewhere classified - Product label incorrectly lists Scopolamine Hydrocodone as an active ingredient on the side panel instead of Scopolamine Hydrobromide.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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