Aidapak Recalls Raltegravir Tablets Due to Potential Labeling Errors
Aidapak Services, LLC is recalling Raltegravir 400 mg tablets because they may be mislabeled as other medications. The recall covers specific lots 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 (mislabeling) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Aidapak Services, LLC is voluntarily recalling Raltegravir 400 mg tablets (NDC 00006022761) due to a labeling error. The agency identified that the Raltegravir tablets may be potentially mislabeled as Hydrocortisone 5 mg tablets or Hyoscyamine Sulfate SL 0.125 mg tablets. This classification is designated as FDA Class II.
The affected product consists of 183 tablets per package. The repacked drugs were distributed in Arizona, California, Oregon, and Washington. Specific pedigree codes and expiration dates are associated with the recall, including Pedigree AD60272_19 (EXP 5/22/2014), Pedigree W003680 (EXP 6/25/2014), and Pedigree AD21790_22 (EXP 5/1/2014).
Patients and healthcare providers should check their medication labels and contact their pharmacist or healthcare provider if they have questions regarding this recall. No specific instructions for disposal or return are provided in the source text.
The recalled product
- Product
- RALTEGRAVIR, Tablet, 400 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00006022761.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 183
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 (8)
- RALTEGRAVIR
- Tablet
- 400 mg has the following codes: Pedigree: AD60272_19
- EXP: 5/22/2014
- Pedigree: W003680
- EXP: 6/25/2014
- Pedigree: AD21790_22
- EXP: 5/1/2014.
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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