Reported Apr 6, 2016 · Terminated
Phenobarbital/Hyoscyamine/ Atropine/Scopolamine 16.2/0.1037/0.0194/0.0065 mg DONNATAL ELIXIR, 5 ml Cup grape, Alcohol…
Safecor Health, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Safecor Health, LLC · 317 New Boston St · Woburn, MA · 01801-6231
Is this the product you have?
- Phenobarbital/Hyoscyamine/ Atropine/Scopolamine 16.2/0.1037/0.0194/0.0065 mg DONNATAL ELIXIR, 5 ml Cup grape, Alcohol 23.8%, Rx Only
- MFGConcordia
- PKG BYSAFECOR HEALTH, WOBURN, MA, C5921242304
- Lot codes and dates
Lot #: 914227Exp 06/16
- Amount recalled
- 23 cups
Where it was sold
Why it was recalled
Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml instead of 10 ml.
This product could cause temporary or reversible health problems — stop using it.
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