Drug 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.
D-0355-2024
Product summary
- Event
- Event 93911
- Status
- Completed
- Classification
- Class II
- Quantity
- 3,600 cartons
- Official record key
drug-enforcement:D-0355-2024
Official wording
Reason: Subpotent Drug: Out of specification for assay
Code information: Lot #0013R; Exp. 01/2026
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Subpotent