The Recall Desk
ModerateFDA (Drugs)·D-922-2014·Announced 2014-01-29

FDA Recalls Levothyroxine Sodium Tablets Due to Potential Labeling Error

Aidapak Services is recalling Levothyroxine Sodium 112 mcg tablets because they may have been mislabeled as Raltegravir 400 mg.

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 (mislabeling) without reported injuries or illnesses, fitting the criteria for moderate severity.

Plain-English summary

Aidapak Services, LLC is recalling Levothyroxine Sodium, Tablet, 112 mcg, NDC 00527134601, due to a labeling error. The recalled product may have been mislabeled as Raltegravir, Tablet, 400 mg, NDC 00006022761. The specific pedigree for the recalled Levothyroxine is AD60272_22 with an expiration date of 5/22/2014.

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The recall is classified as FDA Class II, indicating a situation that might cause temporary or medically reversible adverse health consequences.

Patients and healthcare providers should verify the labeling of their Levothyroxine Sodium 112 mcg tablets. If the product matches the description and pedigree listed above, it should be returned to the pharmacy or discontinued use pending further instructions from a healthcare professional.

The recalled product

Product
LEVOTHYROXINE SODIUM, Tablet, 112 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00527134601.
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)

  • LEVOTHYROXINE SODIUM
  • Tablet
  • 112 mcg has the following codes: Pedigree: AD60272_22
  • 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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