The Recall Desk
ModerateFDA (Drugs)·D-949-2014·Announced 2014-01-29

FDA Recalls Isoniazid Tablets Due to Potential Labeling Errors

Aidapak Services, LLC is recalling Isoniazid 300 mg tablets because they may have been mislabeled as other prescription drugs.

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 and involves a labeling error (label mixup) without reported injuries or illnesses, which aligns with the rubric for moderate severity involving minor labeling errors or voluntary precautionary recalls.

Plain-English summary

Aidapak Services, LLC is voluntarily recalling Isoniazid, Tablet, 300 mg, NDC 00555007102, in 600-tablet packages. The recall was initiated because the medication may have been mislabeled as other prescription drugs, including hydroxyzine pamoate, cetirizine HCl, ranolazine ER, or duloxetine HCl DR.

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The affected lots have pedigree codes W003691, AD32757_31, AD32757_28, and AD60272_70, with expiration dates ranging from May 13, 2014, to June 26, 2014.

Consumers should check their medication packaging for the NDC 00555007102 and the specific pedigree codes listed above. If the medication matches these details, consumers should stop using it and contact their healthcare provider or pharmacist for guidance on appropriate disposal or replacement.

The recalled product

Product
ISONIAZID, Tablet, 300 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00555007102.
Affected units
600

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)

  • ISONIAZID
  • Tablet
  • 300 mg has the following codes: Pedigree: W003691
  • EXP: 6/26/2014
  • Pedigree: AD32757_31
  • EXP: 5/13/2014
  • Pedigree: AD32757_28
  • Pedigree: AD60272_70
  • EXP: 5/22/2014.

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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