Drug 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.
D-0785-2016
Product summary
- Event
- Event 72948
- Status
- Terminated
- Classification
- Class II
- Quantity
- 23 cups
- Official record key
drug-enforcement:D-0785-2016
Official wording
Reason: Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml instead of 10 ml.
Code information: Lot #: 914227; Exp 06/16
Distribution pattern: NY
Derived failure modes
-
Labeling or packaging
Labeling: Label Error