Donnatal Prescription Drug Recalled for Incorrect Ingredient Labeling
Rx PAK is recalling Donnatal tablets because the label incorrectly lists Scopolamine Hydrocodone instead of Scopolamine Hydrobromide.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, and the issue is a minor labeling error.
Plain-English summary
Rx PAK is recalling 2,530 bottles of Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) tablets. The recall is due to a labeling error where the product label incorrectly lists Scopolamine Hydrocodone as an active ingredient on the side panel instead of Scopolamine Hydrobromide.
The affected product is a 100-count bottle, prescription-only medication manufactured for Concordia Pharmaceuticals, Inc., and repackaged by RxPak, a division of McKesson. The recall covers lots 107934 (Exp 9/16) and 108060 (Exp 5/16) with NDC 59212-425-10. The product was distributed nationwide.
Consumers with this product should contact their pharmacist or healthcare provider for guidance. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
The recalled product
- Product
- DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE)
- Brand
- DONNATAL
- Manufacturer
- Rx PAK
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 2,530
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 #: 107934 Exp 9/16
- 108060 Exp 5/16
UPCs (1)
- 0359212425102
Distribution
Distributed nationwide across the United States.
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