Aidapak Recalls Hydrochlorothiazide Tablets Due to Potential Label Mixup
Aidapak Services, LLC is recalling Hydrochlorothiazide 12.5 mg tablets because they may be mislabeled as Chlordiazepoxide HCl 25 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, which typically involves a temporary or medically reversible adverse health consequence. The hazard is a labeling mixup, which fits the criteria for moderate severity involving labeling errors.
Plain-English summary
Aidapak Services, LLC is voluntarily recalling Hydrochlorothiazide Tablets, 12.5 mg, NDC 16729018201. The recall was initiated due to a labeling error where the product may be potentially mislabeled as Chlordiazepoxide HCl, Capsule, 25 mg, NDC 00555015902.
The affected product is identified by the pedigree AD46414_25 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 this specific NDC and pedigree. If the product is found, it should be returned to the distributor or the recalling firm. Patients should consult their healthcare provider if they have questions regarding their medication.
The recalled product
- Product
- HYDROCHLOROTHIAZIDE Tablet, 12.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16729018201
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Tablets
- 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 (3)
- HYDROCHLOROTHIAZIDE Tablet
- 12.5 mg has the following code Pedigree: AD46414_25
- 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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