FDA Recalls Mislabeled HydrALAZINE Tablets Due to Label Mixup
Aidapak Services is recalling HydrALAZINE HCl tablets because they may be mislabeled as other prescription drugs. The recall covers repacked drugs distributed in four western states.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text identifies this as an FDA Class II recall involving a label mixup between different prescription drugs. Per the rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when there is a risk of administering the wrong medication.
Plain-English summary
Aidapak Services, LLC is recalling HydrALAZINE HCl Tablet, 100 mg, NDC 23155000401, due to a labeling error. The FDA classifies this as a Class II recall, indicating a situation where use of, or exposure to, the product may cause temporary or medically reversible adverse health consequences.
The specific hazard is a label mixup where the HydrALAZINE tablets may be mislabeled as DOXEPIN HCL Capsule, 150 mg; DOCUSATE SODIUM Capsule, 250 mg; or LEVOTHYROXINE SODIUM Tablet, 112 mcg. The affected lots have pedigree codes AD46312_13, AD73652_4, and AD30197_7, with expiration dates in May 2014.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. Patients and healthcare providers should check their medication labels and contact their pharmacist or prescriber if they have received these specific lots to ensure they are taking the correct medication.
The recalled product
- Product
- hydrALAZINE HCl Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23155000401
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Affected units
- 400
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 (7)
- hydrALAZINE HCl Tablet
- 100 mg has the following codes Pedigree: AD46312_13
- EXP: 5/16/2014
- Pedigree: AD73652_4
- EXP: 5/29/2014
- Pedigree: AD30197_7
- EXP: 5/9/2014.
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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