Aidapak Recalls Niacin ER Tablets Due to Potential Label Mixup
Aidapak Services, LLC is recalling Niacin ER 500 mg tablets because they may have been mislabeled as other prescription drugs.
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 recalling Niacin ER, Tablet, 500 mg (NDC 00074307490) due to a labeling error. The source text indicates that the tablets may have potentially been mislabeled as Cholecalciferol, Metaxalone, or Cranberry Extract/Vitamin C capsules.
The recalled product consists of 450 tablets per container. The repacked drugs were distributed in Arizona, California, Oregon, and Washington. Specific pedigree codes and expiration dates are listed in the source, including AD60236_4 (EXP: 5/22/2014), W003739 (EXP: 6/26/2014), W003740 (EXP: 6/26/2014), and AD73637_1 (EXP: 5/30/2014).
Consumers and healthcare providers should check their inventory for these specific NDC and pedigree codes. If the product is found, it should be returned to the distributor or the recalling firm, Aidapak Services, LLC, for disposal or credit.
The recalled product
- Product
- NIACIN ER, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00074307490.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 450
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 (9)
- NIACIN ER
- Tablet
- 500 mg has the following codes: Pedigree: AD60236_4
- EXP: 5/22/2014
- Pedigree: W003739
- EXP: 6/26/2014
- Pedigree: W003740
- Pedigree: AD73637_1
- 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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