Aidapak Recalls Calcitriol Capsules Due to Potential Label Mixup
Aidapak Services, LLC is recalling Calcitriol 0.25 mcg capsules because they may be mislabeled as other prescription drugs. The repacked drugs were distributed in four western states.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a label mixup that could lead to the administration of the wrong medication, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Aidapak Services, LLC is recalling specific lots of Calcitriol, Capsule, 0.25 mcg, NDC 00054000725. The recall was initiated due to a labeling error where the product may be mislabeled as one of three other prescription medications: Anagrelide HCL, Benazepril HCL, or Cinacalcet HCL.
The affected repacked drugs were distributed in Arizona, California, Oregon, and Washington. The specific pedigree codes and expiration dates for the recalled Calcitriol are AD46414_10 (EXP: 5/16/2014), AD52778_13 (EXP: 5/20/2014), and W003638 (EXP: 6/25/2014).
Consumers and healthcare providers should check their inventory for these specific pedigree codes and expiration dates. If the product is found, it should be returned to the distributor or the FDA. Patients should consult their healthcare provider if they have questions regarding their medication.
The recalled product
- Product
- CALCITRIOL, Capsule, 0.25 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00054000725.
- 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 (8)
- CALCITRIOL
- Capsule
- 0.25 mcg has the following codes: Pedigree: AD46414_10
- EXP: 5/16/2014
- Pedigree: AD52778_13
- EXP: 5/20/2014
- Pedigree: W003638
- EXP: 6/25/2014.
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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