Class III · Low risk Terminated
Atropine Sulfate Ophthalmic Solution
Reason Failed Impurities/Degradation Specifications
Donnatal
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
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.
What was recalled
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
- Recalling firm
- Rx PAK
- NDC code
- 59212-425-10
- Origin
- TN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0053-2016
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Atropine recalls
See all
Class I · High risk Ongoing
Atropine Sulfate Injection
Reason Presence of Particulate Matter; identified as glass
Class II · Moderate risk Terminated
Atropine Sulfate Injection
Reason Presence of Particulate Matter: Particulate matter identified as fiber.
Class II · Moderate risk Ongoing
Atropine Sulfate Ophthalmic Solution
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class III · Low risk Ongoing
Atropine Sulfate Ophthalmic Solution
Reason Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
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