Aidapak Recalls Hydralazine HCL Tablets Due to Potential Label Mixup
Aidapak Services, LLC is recalling Hydralazine HCL 25 mg tablets because they may be mislabeled as Docusate Calcium 240 mg capsules.
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 involves a labeling error (label mixup) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Aidapak Services, LLC is recalling Hydralazine HCL 25 mg tablets (NDC 50111032701) due to a potential labeling error. The source text indicates that the Hydralazine HCL tablets may be mislabeled as Docusate Calcium 240 mg capsules (NDC 00536375501).
The affected product is identified by the pedigree AD49610_4 and an expiration date of 5/16/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Consumers and healthcare providers should check their inventory for Hydralazine HCL 25 mg tablets with the specified pedigree and expiration date. If found, these products should be quarantined and returned to the distributor or manufacturer for further instructions.
The recalled product
- Product
- HYDRALAZINE HCL Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 50111032701
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 100
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 (4)
- HYDRALAZINE HCL
- Tablet
- 25 mg has the following code Pedigree: AD49610_4
- EXP: 5/16/2014.
Distribution
Part of a larger recall action
This product is one of 273 recalled by Aidapak Services, LLC 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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