D-0355-2024 Class II
FDA drug recall D-0355-2024 was initiated by Bausch Health Companies, Inc. on Feb 2, 2024 and is designated Class II. Reason for recall: Subpotent Drug: Out of specification for assay Affected quantity: 3,600 cartons.
Recall details
- Product Type
- Drugs
- Report Date
- Mar 6, 2024
- Initiation Date
- Feb 2, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,600 cartons
Product description
Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1,680mg, This packet contains 40mg of omeprazole and 1,680mg of sodium bicarbonate, Directions for Use: Empty packet contents into a small cup containing 1 to 2 tablespoons of WATER. DO NOT USE OTHER LIQUIDS OR FOODS. Stir well and drink immediately. Rx Only, Distributed by: Oceanside Pharmaceuticals, a division of Bausch Health US, LLC, Bridgewater, NJ 08807, NDC 68682-991-30.
Reason for recall
Subpotent Drug: Out of specification for assay
Distribution pattern
Nationwide
Code information
Lot #0013R; Exp. 01/2026
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0355-2024
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026