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.

Recall Number: D-0785-2016

Firm: Safecor Health, LLC

Classification: Class II

Status: Terminated

Report Date: 20160406

Initiation Date: 20150716

Termination Date: 20160330

Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml instead of 10 ml.

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.