Aidapak Recalls Calcitriol Capsules Due to Potential Labeling Mixup
Aidapak Services, LLC is recalling Calcitriol 0.5 mcg capsules because they may be mislabeled as Niacin or Isoniazid. The repacked drugs were 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 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 mixup. Per the rubric, minor labeling errors and voluntary precautionary recalls are typically rated as Moderate.
Plain-English summary
Aidapak Services, LLC is recalling Calcitriol Capsules, 0.5 mcg, NDC 63304024001, due to a labeling mixup. The source text indicates that the Calcitriol capsules may be potentially mislabeled as Niacin TR, Tablet, 250 mg, or Isoniazid, Tablet, 300 mg.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The affected Calcitriol capsules have the following pedigree and expiration codes: Pedigree W003730, EXP 6/26/2014, and Pedigree AD32757_10, EXP 5/14/2014.
Consumers should check their medication for these specific codes and contact their healthcare provider or pharmacist if they have questions regarding the recall.
The recalled product
- Product
- CALCITRIOL Capsule, 0.5 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63304024001
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 500
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 (6)
- CALCITRIOL
- Capsule
- 0.5 mcg has the following codes Pedigree: W003730
- EXP: 6/26/2014
- Pedigree: AD32757_10
- EXP: 5/14/2014.
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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