Aidapak Recalls Naproxen Tablets Due to Potential Labeling Errors
Aidapak Services, LLC is recalling Naproxen 500 mg tablets because they may be mislabeled as Thiothixene or Hydrochlorothiazide.
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 corresponds to a moderate severity score of 2 under the rubric for minor labeling errors or low-risk contamination.
Plain-English summary
Aidapak Services, LLC is recalling Naproxen, Tablet, 500 mg, Rx only, NDC 05374601901. The recall was initiated due to a labeling error where the product may be mislabeled as Thiothixene, Capsule, 1 mg, or Hydrochlorothiazide, Tablet, 12.5 mg.
The affected repacked drugs were distributed in Arizona, California, Oregon, and Washington. The specific lot codes involved are Pedigree AD54516_1 with an expiration date of 5/20/2014, and Pedigree AD68025_8 with an expiration date of 5/28/2014.
Consumers and healthcare providers should check their inventory for these specific lot codes and expiration dates. If the product is found, it should be returned to the distributor or a healthcare professional should be contacted for guidance on disposal or replacement.
The recalled product
- Product
- NAPROXEN, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 05374601901
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 200
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)
- NAPROXEN
- Tablet
- 500 mg has the following codes Pedigree: AD54516_1
- EXP: 5/20/2014
- Pedigree: AD68025_8
- EXP: 5/28/2014.
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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