Safecor Health, LLC recalls Phenobarbital/Hyoscyamine/ Atropine/Scopolamine 16.2/0.1037/0.0194/0.0065 mg DONNATAL ELIXIR, 5 ml Cup grape, Alcohol 2
Recalled April 6, 2016 · FDA recall D-0785-2016 · Safecor Health
Hazard
Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml instead of 10 ml. · FDA Class II
Units
23 cups
Sold at
NY
Description
Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml instead of 10 ml.
Product
Phenobarbital/Hyoscyamine/ Atropine/Scopolamine 16.2/0.1037/0.0194/0.0065 mg DONNATAL ELIXIR, 5 ml Cup grape, Alcohol 23.8%, Rx Only, MFG: Concordia, PKG BY: SAFECOR HEALTH, WOBURN, MA, C5921242304.
Manufacturer(s)
Safecor Health, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →