D-0749-2022 Class II Terminated
FDA drug recall D-0749-2022 was initiated by DASH Pharmaceuticals LLC on March 11, 2022 and is designated Class II. Reason for recall: Labeling: Label Mix-Up The recall status is terminated (terminated February 16, 2023). Affected quantity: 45,940 Unit Dose Cups.
Recall Details
- Product Type
- Drugs
- Report Date
- April 13, 2022
- Initiation Date
- March 11, 2022
- Termination Date
- February 16, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 45,940 Unit Dose Cups
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.
Reason for Recall
Labeling: Label Mix-Up
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: a) 376908P40, Exp. Date 02/28/2023; b) 376908P100, Exp. Date 02/28/2023