Sucralfate Oral Suspension, USP 1g/10mL, packaged in a) 40 case of 10 mL unit Dose Cups (NDC 69339-148-17) and b) 100 ca
Summary
The FDA issued a Class II for Sucralfate Oral Suspension, USP 1g/10mL, packaged in a) 40 case of 10 mL unit Do by DASH Pharmaceuticals LLC. Reason: Labeling: Label Mix-Up.
Details
Source
Drug Recall
External ID
D-0749-2022
Action Date
2022-04-13
Status
Terminated
Category
drug
Product Description
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.
Lot/Code Info: Lot #: a) 376908P40, Exp. Date 02/28/2023; b) 376908P100, Exp. Date 02/28/2023
Quantity Affected: 45,940 Unit Dose Cups
Reason for Recall
Labeling: Label Mix-Up
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-11
Company
Upper Saddle River, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 47 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (DASH Pharmaceuticals LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does DASH Pharmaceuticals LLC have FDA actions?
This is the only FDA action we have on record for DASH Pharmaceuticals LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0749-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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