PlainRecalls
FDA Drug Moderate Class II Completed

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.

Reported: March 6, 2024 Initiated: February 2, 2024 #D-0355-2024

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

Details

Units Affected
3,600 cartons
Distribution
Nationwide
Location
Bridgewater, NJ

Frequently Asked Questions

What product was recalled?
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.. Recalled by Bausch Health Companies, Inc.. Units affected: 3,600 cartons.
Why was this product recalled?
Subpotent Drug: Out of specification for assay
Which agency issued this recall?
This recall was issued by the FDA Drug on March 6, 2024. Severity: Moderate. Recall number: D-0355-2024.