Pantoprazole Sodium Tablets Recalled for Potential Labeling Mixup
Aidapak Services is recalling Pantoprazole Sodium 20 mg tablets because they may be mislabeled as Dronedarone HCL 400 mg.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly given the risk of administering the wrong medication.
Plain-English summary
Aidapak Services, LLC is recalling specific lots of Pantoprazole Sodium DR Tablets, 20 mg, due to a potential labeling mixup. The recalled product, identified by NDC 62175018046 and pedigree AD52778_64, may be incorrectly labeled as Dronedarone HCL Tablets, 400 mg (NDC 00024414260, pedigree AD52778_52). Both products share an expiration date of May 20, 2014.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. This recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Patients and healthcare providers should check their medication labels and contact their pharmacist or prescriber if they have the affected product. Do not take the medication if the label does not match the prescription.
The recalled product
- Product
- PANTOPRAZOLE SODIUM DR Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 62175018046
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 90
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 (3)
- PANTOPRAZOLE SODIUM DR Tablet
- 20 mg has the following code Pedigree: AD52778_64
- EXP: 5/20/2014.
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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