February 2024 FDA Recall Omeprazole And Sodium Bicarbonate by Bausch Health Companies, Inc.
D-0355-2024 - Subpotent Drug
This Class II drug recall was voluntarily initiated by Bausch Health Companies, Inc. on February 2, 2024 for the product Omeprazole And Sodium Bicarbonate. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently completed.
Recall Number: D-0355-2024
Subpotent Drug: Out of specification for assay
02-02-2024
03-06-2024
3,600 cartons
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Bausch Health Companies, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
