FDAFDA · Food and drugs·Recall number D-0785-2016
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.
Published April 6, 2016 · Recall initiated: July 16, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml instead of 10 ml.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Safecor Health, LLC
- Distributor
- NY
- Lot
- Lot #: 914227; Exp 06/16
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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