Sandoz Recalls Triamterene and Hydrochlorothiazide Tablets Due to Cross-Contamination
Sandoz Incorporated is recalling specific lots of Triamterene and Hydrochlorothiazide Tablets due to the presence of unrelated ingredients.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 agency classified this as an FDA Class III recall, which is defined as unlikely to cause adverse health consequences. The hazard involves cross-contamination with unrelated ingredients, which fits the criteria for a moderate severity rating involving low-risk contamination or voluntary precautionary measures.
Plain-English summary
Sandoz Incorporated is recalling 11,680 bottles of Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, 500-count bottles. The affected product is prescription-only and was distributed nationwide in the USA and Puerto Rico. The specific lots involved are GW8264 and HD3095, with an expiration date of 12/18.
The recall was initiated because of cross-contamination with other products. The source text indicates the presence of unrelated ingredients, specifically traces of Lisinopril, Mannitol, Iron, Calcium, and Phosphorous.
Consumers should check their medication for the NDC 0781-5067-05 and the lot numbers GW8264 or HD3095. If the product matches these details, patients should contact their healthcare provider or pharmacist for guidance on discontinuing use and obtaining a replacement.
The recalled product
- Product
- Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, 500-count bottles, Rx only, Manufactured by Sandoz, Inc., Princeton, NJ 08540, NDC 0781-5067-05.
- Manufacturer
- Sandoz Incorporated
- Category
- Drug — Prescription Medication
- Affected units
- 11,680
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 (3)
- Lot #: GW8264
- HD3095
- Exp 12/18
Distribution
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