Safety Alerts & Recalls

What does this mean?

This recall for Phenobarbital/Hyoscyamine/Atropine/Scopolamine 16.2/0.1037/0.019 4/0.0065 mg DONNATAL ELIXIR from Safecor Health, LLC was issued at a warehouse and pharmacy level only. The FDA and the manufacturer have determined that any recalled product that may have been dispensed to patients does not pose a significant health risk. If you take Phenobarbital/Hyoscyamine/ Atropine/Scopolamine 16.2/0.1037/0.019 4/0.0065 mg DONNATAL ELIXIR and are concerned, you should speak to your doctor.

Safecor Health, LLC Recalls Single Lot of Donnatal Elixir

Safecor Health, LLC has recalled a single lot of Phenobarbital/Hyoscyamine/Atropine/Scopolamine 16.2/0.1037/0.019 4/0.0065 mg DONNATAL ELIXIR. Lot number 914227 is being recalled because the label was incorrect in this lot.

Phenobarbital/Hyoscyamine/Atropine/Scopolamine is used in the treatment of certain digestion problems. This recall alert only applies to the single lot of the generic Phenobarbital/Hyoscyamine/Atropine/Scopolamine 16.2/0.1037/0.019 4/0.0065 mg DONNATAL ELIXIR made by Safecor Health, LLC. No other Phenobarbital/Hyoscyamine/ Atropine/Scopolamine products were involved in this recall.

To search and view the FDA notice about this recall, please visit: more information here

Source: FDA
Publication Date: 2016-07-06
Last Updated: 2016-07-06

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