Bisoprolol Fumarate and Hydrochlorothiazide Tablets Recalled for Failed Quality Specifications
Glenmark Pharmaceuticals is recalling Bisoprolol Fumarate and Hydrochlorothiazide Tablets due to failed impurities and degradation specifications. The recall affects 480 bottles distributed nationwide.
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: This is an FDA Class III recall with no reported illnesses or injuries to date. The failed quality specifications (impurities and degradation) represent a voluntary, precautionary measure rather than a confirmed health hazard. Class III recalls are typically the lowest priority assigned by the FDA.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, packaged in 100-count bottles (NDC 68462-879-01 and related package numbers). This is a prescription medication used to treat high blood pressure and certain heart rhythm conditions.
The recall was issued because the affected lot failed impurities and degradation specifications during quality testing. The specific nature of the impurities or the extent of degradation is not detailed in this notice.
The recall affects 480 bottles distributed nationwide in the United States. The implicated lot number is 17212352, with an expiration date of 11/31/2023.
Patients taking this medication should contact their healthcare provider or pharmacist immediately. Do not stop taking your blood pressure medication abruptly without medical guidance, as doing so could be harmful. Your pharmacist can determine whether your medication is affected and can provide an alternative if necessary.
The recalled product
- Product
- BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE)
- Brand
- BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Antihypertensive
- Hazard
- impurity
- degradation
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# 17212352
- Exp 11/31/2023
UPCs (3)
- 0368462880302
- 0368462879306
- 0368462878309
Distribution
Distributed nationwide across the United States.
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