Recalls / Class III
Class IIID-0053-2016
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
- Brand name
- Donnatal
- Generic name
- Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide
- Active ingredients
- Atropine Sulfate, Hyoscyamine Sulfate, Phenobarbital, Scopolamine Hydrobromide
- Route
- Oral
- NDC
- 59212-425
- Affected lot / code info
- Lot #: 107934 Exp 9/16, 108060 Exp 5/16
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.
Recalling firm
- Firm
- Rx PAK
- Manufacturer
- Advanz Pharma (US) Corp.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 4971 Southridge Blvd Ste 111-115, N/A, Memphis, Tennessee 38141-8300
Distribution
- Quantity
- 2530 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-10-13
- FDA classified
- 2015-10-21
- Posted by FDA
- 2015-10-28
- Terminated
- 2016-06-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0053-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.