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Class II · ModerateRecall completed

Omeprazole And Sodium Bicarbonate

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #0013R; Exp. 01/2026
Where it was soldNationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Subpotent Drug: Out of specification for assay

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byOceanside Pharmaceuticals
Brand nameOMEPRAZOLE AND SODIUM BICARBONATE
Generic nameOMEPRAZOLE, SODIUM BICARBONATE
Active ingredient(s)OMEPRAZOLE, SODIUM BICARBONATE
Distributed by / forOceanside Pharmaceuticals, a division of Bausch Health US, LLC, Bridgewater, NJ 08807
NDC68682-991-30
Show the full FDA record
Full product labelOmeprazole 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.
Recalling firmBausch Health Companies, Inc.
DistributionNationwide
Quantity3,600 cartons
Recall initiated2024-02-02
Report date2024-03-06
Recall completed—
Recall numberD-0355-2024
ClassificationClass II
FDA statusCompleted
Origin on fileBridgewater NJ United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.