Kremers Urban Recalls Omeprazole Capsules for Acid Resistance Failure
Kremers Urban Pharmaceuticals is recalling 3,867 bottles of Omeprazole 20 mg capsules because some may not meet acid resistance specifications.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Kremers Urban Pharmaceuticals, Inc. is recalling 3,867 bottles of Omeprazole Delayed-Release Capsules, USP, 20 mg. The affected product is Lot Number 59627 with an expiration date of 02/2014. The product was distributed in Kentucky and Tennessee.
The recall was initiated because some capsules are suspected to not meet the specification for acid resistance over time. This is a Class II recall, indicating a situation that might cause temporary or medically reversible adverse health consequences.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for further instructions. The product is a prescription-only medication.
The recalled product
- Product
- OMEPRAZOLE (OMEPRAZOLE)
- Brand
- OMEPRAZOLE
- Manufacturer
- Kremers Urban Pharmaceuticals, Inc.
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 3,867
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Number 59627
- Expiration Date 02/2014
UPCs (3)
- 0362175136329
- 0362175114327
- 0362175118325
Distribution
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