← FDA ENFORCEMENT
D-0355-2024Class II

Bausch Health Companies, Inc.

Recalling firm
Bausch Health Companies, Inc.
Product type
Drug
Status
Completed
Report date
2024-03-06
Distribution
Nationwide
Firm state
NJ
Product quantity
3,600 cartons
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Subpotent Drug: Out of specification for assay

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.

Code / lot info

Lot #0013R; Exp. 01/2026

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.