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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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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