Omeprazole And Sodium Bicarbonate Capsule
FDA Recall NDC 68682-102
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Omeprazole And Sodium Bicarbonate (NDC 68682-102). A significant event, classified as Class II, was initiated on Feb 02, 2024 by Oceanside Pharmaceuticals. The reported reason for this action was: "Subpotent Drug: Out of specification for assay"
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Completed
Subpotent Drug: Out of specification for assay
Feb 02, 2024
Mar 06, 2024
3,600 cartons
Recall Profile & Regulatory Data
Event ID
93911
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Bausch Health Companies, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
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.
Batch or Lot Expiration Information
Lot# 0013R; Exp. 01/2026
Affected Packages Involved in this Recall
68682-990-30Product
68682-991-30Product
68682-102-30Product
68682-104-30Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
