Drug & medication recalls Moderate risk

Bausch Health Companies, Inc. recalls Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1,680mg, This packet contains 40mg of omeprazole and 1,680mg…

Recall date
February 2, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0355-2024
FDA classification
Class II
Brand / firm
Bausch Health Companies, Inc.
Sold / distributed
Nationwide

Why it was recalled

Subpotent Drug: Out of specification for assay

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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.

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