Aidapak Recalls Niacin TR Capsules Due to Potential Labeling Error
Aidapak Services, LLC is recalling Niacin TR capsules because they may have been mislabeled as Methylergonovine Maleate tablets.
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 a labeling error that could cause temporary or medically reversible health consequences. The rubric assigns a score of 2 for minor labeling errors and voluntary precautionary recalls where no injuries are reported.
Plain-English summary
Aidapak Services, LLC is recalling Niacin TR, Capsule, 250 mg (NDC 00904062960) due to a potential labeling error. The recall is initiated because the product may have been mislabeled as Methylergonovine Maleate, Tablet, 0.2 mg (NDC 43386014028).
The affected product is identified by Pedigree W003478 and an expiration date of 6/20/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Consumers and healthcare providers should check their inventory for Niacin TR capsules with the specified pedigree and expiration date. If found, the product should be returned to the distributor or disposed of according to local regulations. Patients should consult their healthcare provider if they have questions regarding the medication they have received.
The recalled product
- Product
- NIACIN TR, Capsule, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00904062960.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 100
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 (4)
- NIACIN TR
- Capsule
- 250 mg has the following codes: Pedigree: W003478
- EXP: 6/20/2014.
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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