Drug Recall: Hydralazine Hydrochloride Tablets Due to Improper Storage
Cardinal Healthcare is recalling Hydralazine Hydrochloride tablets nationwide because products were exposed to temperatures outside labeled storage conditions due to manufacturing practice deviations.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a prescription cardiovascular medication where improper temperature exposure could affect drug potency and efficacy. While no illnesses or injuries have been reported, this represents a risk-of-harm scenario involving a critical quality parameter for pharmaceutical products.
Plain-English summary
Cardinal Healthcare is recalling Hydralazine Hydrochloride Tablets, USP, 25 mg (NDC 23155-002-01 and related package codes) distributed by Avet Pharmaceuticals Inc. nationwide. The recall affects batch numbers G210553 and G210551.
The recall was initiated due to Good Manufacturing Practice (CGMP) deviations. Products in these batches were exposed to temperatures outside the labeled storage conditions, which could compromise the drug's quality and potency.
Patients taking this medication should consult their healthcare provider or pharmacist before discontinuing use. Persons who have this product should contact Cardinal Healthcare or their pharmacy for return or disposal instructions. Healthcare providers should verify whether their patients received affected batches and counsel them appropriately.
The recalled product
- Product
- HYDRALAZINE HYDROCHLORIDE (HYDRALAZINE HYDROCHLORIDE)
- Brand
- HYDRALAZINE HYDROCHLORIDE
- Manufacturer
- CARDINAL HEALTHCARE
- Affected units
- 2
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)
- Batch G210553
- G210551
UPCs (3)
- 0323155003017
- 0323155004014
- 0323155002010
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 42 recalled by CARDINAL HEALTHCARE under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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