Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1,680mg, This packet contains 40mg of omeprazole and 1,680mg
Summary
The FDA issued a Class II for Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1,680mg, This packet by Bausch Health Companies, Inc.. Reason: Subpotent Drug: Out of specification for assay.
Details
Source
Drug Recall
External ID
D-0355-2024
Action Date
2024-03-06
Status
Completed
Category
drug
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.
Lot/Code Info: Lot #0013R; Exp. 01/2026
Quantity Affected: 3,600 cartons
Reason for Recall
Subpotent Drug: Out of specification for assay
Distribution
Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2024-02-02
Company
Bridgewater, 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 63 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 (Bausch Health Companies, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Bausch Health Companies, Inc. have FDA actions?
This is the only FDA action we have on record for Bausch Health Companies, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0355-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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