Drug Enforcement D-0355-2024

Subpotent Drug: Out of specification for assay

Status

Completed

Classification

Class II

Report Date

March 6, 2024

Termination Date

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Product Information

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.
Product quantity
3,600 cartons
Reason for recall
Subpotent Drug: Out of specification for assay
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Bausch Health Companies, Inc.
Address
400 Somerset Corporate Blvd

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0355-2024
Event ID
93911
Recall initiation date
February 2, 2024
Center classification date
February 28, 2024
Code info
Lot #0013R; Exp. 01/2026
More code info
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