Sandoz Recalls Subpotent Fosinopril Sodium and Hydrochlorothiazide Tablets
Sandoz Inc. is recalling specific lots of Fosinopril Sodium and Hydrochlorothiazide tablets because the hydrochlorothiazide content was subpotent at the 9-month time point.
What this means for you
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, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The source text does not report any illnesses or injuries, and the hazard is a subpotent ingredient rather than a toxic contaminant, fitting the Moderate criteria for a voluntary precautionary recall of a prescription drug.
Plain-English summary
Sandoz Inc. is recalling 2,491 bottles of 100 tablets each of Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg, Rx Only. The affected product is identified by Lot CU0856 and NDC 0185-0341-01. The recall is due to the hydrochlorothiazide component being subpotent at the 9-month time point.
The product was distributed nationwide. This is a prescription-only medication, meaning it was dispensed by pharmacies to patients with valid prescriptions.
Consumers with this specific lot of medication should contact their healthcare provider or pharmacist for guidance on how to proceed. They should not continue to use the medication without professional advice.
The recalled product
- Product
- Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg, Rx Only, 100 Tablets, Sandoz Inc. Princeton, NJ 08540 ---NDC 0185-0341-01,
- Manufacturer
- Sandoz Inc
- Category
- Drug — Prescription Medication
- Hazard
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 (1)
- Lot CU0856
Distribution
Distributed nationwide across the United States.
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