Aidapak Recalls Mislabeled Pantoprazole Sodium DR Tablets
Aidapak Services is recalling 20 mg Pantoprazole Sodium DR tablets because they may be mislabeled as Hyoscyamine Sulfate or Multivitamin/Multimineral.
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 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 180-count bottles of Pantoprazole Sodium DR, Tablet, 20 mg (NDC 00008060601) due to a labeling error. The recalled product may be mislabeled as Hyoscyamine Sulfate SL, Tablet, 0.125 mg (NDC 00574025001) or Multivitamin/Multimineral, Tablet, 0 mg (NDC 65162066810).
The affected repacked drugs were distributed in Arizona, California, Oregon, and Washington. The recall involves specific pedigree codes: AD60272_28 (Expiration: 5/22/2014) and AD73525_19 (Expiration: 5/30/2014).
Consumers should check their medication bottles for the NDC 00008060601 and the listed pedigree codes. 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
- PANTOPRAZOLE SODIUM DR, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00008060601.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 180
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)
- PANTOPRAZOLE SODIUM DR
- Tablet
- 20 mg has the following codes: Pedigree: AD60272_28
- EXP: 5/22/2014
- Pedigree: AD73525_19
- EXP: 5/30/2014
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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