Pancrelipase DR Capsules Recalled for Potential Label Mixup
Aidapak Services is recalling Pancrelipase DR capsules due to a potential label mixup with Aspirin/ER Dipyridamole. 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, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The hazard is a labeling error (label mixup) rather than a direct contamination or structural defect, fitting the Moderate severity criteria for minor labeling errors or low-risk contamination.
Plain-English summary
Aidapak Services, LLC is recalling Pancrelipase DR capsules (12000/38000/60000 USP units) because they may be potentially mislabeled as Aspirin/ER Dipyridamole capsules (25 mg/200 mg). The recall involves repacked drugs distributed in Arizona, California, Oregon, and Washington.
The affected Pancrelipase DR capsules have the pedigree AD70639_7 and an expiration date of 5/29/2014. The potential mislabeling involves Aspirin/ER Dipyridamole capsules with pedigree AD70639_4 and an expiration date of 7/28/2013.
Consumers should check their medication for these specific codes and expiration dates. If the product matches the description, they should contact their pharmacist or healthcare provider for instructions on how to return the medication.
The recalled product
- Product
- PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units, Rx only, Distributed by: AidaPak Service, LLC, NDC 00032121207.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
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 (4)
- PANCRELIPASE DR
- Capsule
- 12000 /38000 /60000 USP units has the following codes: Pedigree: AD70639_7
- EXP: 5/29/2014.
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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