Sucralfate Oral Suspension Recalled Due to Label Mix-Up
DASH Pharmaceuticals is recalling Sucralfate Oral Suspension nationwide due to a labeling mix-up affecting approximately 45,940 unit dose cups.
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: FDA Class II recall with no reported illnesses or injuries. The source indicates a labeling mix-up with no specified hazard details, consistent with a minor labeling error.
Plain-English summary
DASH Pharmaceuticals LLC is recalling Sucralfate Oral Suspension, USP 1g/10mL, packaged in 10 mL unit dose cups, due to a labeling mix-up. The recall involves two lot numbers: Lot #376908P40 (40-case, NDC 69339-148-17, expiring 02/28/2023) and Lot #376908P100 (100-case, NDC 69339-148-19, expiring 02/28/2023). Approximately 45,940 unit dose cups were distributed nationwide.
Patients and healthcare providers with affected batches should consult a healthcare provider for guidance.
The recalled product
- Product
- Sucralfate Oral Suspension, USP 1g/10mL, packaged in a) 40 case of 10 mL unit Dose Cups (NDC 69339-148-17) and b) 100 case of 10 mL Unit Dose Cups (NDC 69339-148-19) Rx Only, Dash Pharmaceuticals, Upper Saddle River, NJ 07458.
- Manufacturer
- DASH Pharmaceuticals LLC
- Category
- Drug
- Hazard
- Affected units
- 45,940
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 (3)
- Lot #: a) 376908P40
- Exp. Date 02/28/2023
- b) 376908P100
Distribution
Distributed nationwide across the United States.
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