Recalls / Class II
Class IID-0355-2024
Product
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.
- Brand name
- Omeprazole And Sodium Bicarbonate
- Generic name
- Omeprazole, Sodium Bicarbonate
- Active ingredients
- Omeprazole, Sodium Bicarbonate
- Route
- Oral
- NDCs
- 68682-102, 68682-990, 68682-991, 68682-104
- FDA application
- NDA021849
- Affected lot / code info
- Lot #0013R; Exp. 01/2026
Why it was recalled
Subpotent Drug: Out of specification for assay
Recalling firm
- Firm
- Bausch Health Companies, Inc.
- Manufacturer
- Oceanside Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Somerset Corporate Blvd, Bridgewater, New Jersey 08807-2867
Distribution
- Quantity
- 3,600 cartons
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2024-02-02
- FDA classified
- 2024-02-28
- Posted by FDA
- 2024-03-06
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0355-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.