The Recall Desk
ModerateFDA (Drugs)·D-945-2014·Announced 2014-01-29

Aidapak Recalls Niacin TR Tablets Due to Potential Label Mixup

Aidapak Services is recalling Niacin TR 1000 mg tablets because they may have been mislabeled as 750 mg tablets. The repacked drugs were distributed in four western states.

What this means for you

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 temporary or medically reversible adverse health consequence. The hazard is a labeling mixup between two different strengths of the same drug, which fits the criteria for moderate severity involving labeling errors.

Plain-English summary

Aidapak Services, LLC is recalling Niacin TR, Tablet, 1000 mg (NDC 00536703801) due to a labeling error. The recall is initiated because the 1000 mg tablets may have been mislabeled as Niacin TR, Tablet, 750 mg (NDC 00536703301). The affected product is a prescription-only medication distributed by Aidapak Service, LLC.

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The specific pedigree code for the recalled 1000 mg tablets is AD46414_50, with an expiration date of 5/16/2014. The potentially mislabeled 750 mg tablets have the pedigree code AD46414_56 and the same expiration date.

Consumers and healthcare providers should check their inventory for Niacin TR 1000 mg tablets with the specified pedigree and expiration date. If the product is found, it should be returned to the distributor or disposed of according to local regulations. Patients should consult their healthcare provider if they have questions regarding their medication.

The recalled product

Product
NIACIN TR, Tablet, 1000 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00536703801.
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
  • Tablet
  • 1000 mg has the following codes: Pedigree: AD46414_50
  • EXP: 5/16/2014.

Distribution

Distributed in 4 states:

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.

See all 265 products in this recall →

Same manufacturer · Aidapak Services, LLC

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