Aidapak Recalls Paricalcitol Capsules Due to Potential Labeling Errors
Aidapak Services is recalling Paricalcitol capsules because they may have been mislabeled as Ascorbic Acid or Cholecalciferol.
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 due to a labeling mixup. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries are rated as Moderate.
Plain-English summary
Aidapak Services, LLC is recalling Paricalcitol, Capsule, 1 mcg (NDC 00074431730) due to a labeling error. The product may have been mislabeled as Ascorbic Acid, Tablet, 500 mg (NDC 60258014101) or Cholecalciferol, Capsule, 2000 units (NDC 00536379001).
The recalled Paricalcitol capsules were distributed in Arizona, California, Oregon, and Washington. The affected lots include Pedigree AD23082_22 with an expiration date of 5/6/2014 and Pedigree W002667 with an expiration date of 6/5/2014.
Patients and healthcare providers should check their medication labels and contact their pharmacist or physician if they have received the affected product. The FDA has classified this as a Class II recall, indicating a situation that may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- PARICALCITOL, Capsule, 1 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00074431730.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 60
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)
- PARICALCITOL
- Capsule
- 1 mcg has the following codes: Pedigree: AD23082_22
- EXP: 5/6/2014
- Pedigree: W002667
- EXP: 6/5/2014.
Distribution
Part of a larger recall action
This product is one of 265 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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