Aidapak Recalls Pancrelipase DR Capsules Due to Potential Labeling Errors
Aidapak Services, LLC is recalling Pancrelipase DR capsules because they may be mislabeled as Melatonin or Verapamil HCL. 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 error (label mixup) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Aidapak Services, LLC is recalling Pancrelipase DR Capsules, NDC 42865010302, because the product may be potentially mislabeled as Melatonin, Tablet, 1 mg, or Verapamil HCL, Tablet, 40 mg. The recall is classified as FDA Class II.
The affected repacked drugs were distributed in Arizona, California, Oregon, and Washington. The specific product codes involved are Pedigree W003354 with an expiration date of 6/19/2014, and Pedigree W003171 with an expiration date of 6/13/2014.
Consumers should check their medication for these specific codes and expiration dates. If the product matches the description, they should stop using it and contact their pharmacist or healthcare provider for instructions on how to return the medication.
The recalled product
- Product
- PANCRELIPASE DR Capsule, Rx only, Distributed by: AidaPak Service, LLC, NDC 42865010302
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 200
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 (5)
- PANCRELIPASE DR
- Capsule has the following codes Pedigree: W003354
- EXP: 6/19/2014
- Pedigree: W003171
- EXP: 6/13/2014.
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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