Safecor Health Recalls Donnatal Elixir Due to Labeling Error
Safecor Health is recalling 23 cups of Donnatal Elixir because the label incorrectly lists the dose as 5 ml instead of 10 ml.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a minor labeling error regarding dose identification, which fits the criteria for a moderate severity score.
Plain-English summary
Safecor Health, LLC is recalling 23 cups of Donnatal Elixir, a prescription medication containing phenobarbital, hyoscyamine, atropine, and scopolamine. The product is a grape-flavored elixir with 23.8% alcohol content, manufactured by Concordia and packaged by Safecor Health in Woburn, MA.
The recall was initiated due to a labeling error where the product dose is incorrectly identified as 5 ml instead of the correct 10 ml. The affected lot number is 914227, with an expiration date of 06/16.
The product was distributed in New York. Consumers who have this product should contact their healthcare provider or pharmacist for guidance on how to proceed.
The recalled product
- 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.
- Manufacturer
- Safecor Health, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 23
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 914227
- Exp 06/16
Distribution
Distributed in 1 state:
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