Class II
Terminated
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.
- Company
- Safecor Health, Llc
- Recall Initiated
- July 16, 2015
- Posted
- April 6, 2016
- Recall Number
- D-0785-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 23 cups
- Firm Location
- Woburn, MA, United States
Reason for Recall
Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml instead of 10 ml.
Distribution
NY
Lot / Code Info
Lot #: 914227; Exp 06/16
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