Phenobarbital/Hyoscyamine/ Atropine/Scopolamine recall: Labeling Error
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…
Why was Phenobarbital/Hyoscyamine/ Atropine/Scopolamine recalled?
Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml instead of 10 ml.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 914227; Exp 06/16
- 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…
- Recalling firm
- Safecor Health, LLC
- Quantity
- 23 cups
- Distribution
- NY
- Recall date
- April 6, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)