Bausch Health Companies, Inc.: Drug Recall

Recall #D-0355-2024 · 02/02/2024

Class II: Risk

Recall Details

Recall Number
D-0355-2024
Classification
Class II
Product Type
Drug
Recalling Firm
Bausch Health Companies, Inc.
Status
Completed
Date Initiated
02/02/2024
Location
Bridgewater, NJ, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3,600 cartons

Reason for Recall

Subpotent Drug: Out of specification for assay

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.

Distribution Pattern

Nationwide

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.