Aidapak Recalls Amantadine HCL Tablets Due to Labeling Error
Aidapak Services, LLC is recalling Amantadine HCL 100 mg tablets because they may have been mislabeled as other medications.
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 involves minor labeling errors or low-risk contamination where the probability of serious adverse health consequences is remote.
Plain-English summary
Aidapak Services, LLC is recalling Amantadine HCL, Tablet, 100 mg (NDC 00832011100) due to a labeling error. The recalled tablets may have been mislabeled as Magnesium Chloride, Tablet, 64 mg, or Quetiapine Fumarate, Tablet, 25 mg.
The affected product consists of 2,400 tablets. The specific lots involved have pedigree codes AD54475_1 and AD54475_4, both with an expiration date of May 20, 2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Consumers should check their medication labels for the NDC 00832011100 or the specific pedigree codes listed above. If the product matches the description, patients should contact their healthcare provider or pharmacist for guidance on proper medication management.
The recalled product
- Product
- AMANTADINE HCL, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00832011100.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 2,400
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 (6)
- AMANTADINE HCL
- Tablet
- 100 mg has the following codes: Pedigree: AD54475_1
- EXP: 5/20/2014
- Pedigree: AD54475_4
- EXP: 5/20/2014.
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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