Why it was recalled
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.
Lot numbers, UPCs & expiration codes
Lot #0013R; Exp. 01/2026
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0355-2024
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Feb 2, 2024
- FDA report date
- Mar 6, 2024
- Quantity
- 3,600 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bausch Health Companies, Inc.
Original FDA data
Every field from FDA enforcement report D-0355-2024, exactly as published.
Show all FDA fields
- City
- Bridgewater
- State
- NJ
- Status
- Completed
- Country
- United States
- Event ID
- 93911
- Address
- 400 Somerset Corporate Blvd
- Code information
- Lot #0013R; Exp. 01/2026
- Postal code
- 08807-2867
- Report date
- Mar 6, 2024
- Product type
- Drugs
- Recall number
- D-0355-2024
- Classification
- Class II
- Recalling firm
- Bausch Health Companies, Inc.
- Product quantity
- 3,600 cartons
- Reason for recall
- Subpotent Drug: Out of specification for assay
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Feb 2, 2024
- Initial firm notification
- Letter
- Center classification date
- Feb 28, 2024