The Recall Desk
SevereFDA (Drugs)·D-897-2014·Announced 2014-01-29

Aidapak Recalls Levothyroxine Sodium Tablets Due to Labeling Errors

Aidapak Services, LLC is recalling Levothyroxine Sodium 88 mcg tablets because they may have been mislabeled as other prescription drugs.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this as a Class II recall. Per the rubric, FDA Class II recalls involving potential mislabeling of prescription drugs, which could lead to incorrect treatment, are categorized as Severe.

Plain-English summary

Aidapak Services, LLC is voluntarily recalling Levothyroxine Sodium, Tablet, 88 mcg (NDC 00378180701) due to a labeling error. The recall was initiated because the tablets may have been mislabeled as other medications, including Nebivolol HCL, Melatonin, Isosorbide Dinitrate, and Hydrocortisone.

The affected repacked drugs were distributed in Arizona, California, Oregon, and Washington. The recall covers 600-tablet units with specific pedigree codes and expiration dates ranging from May to June 2014. The FDA has classified this recall as Class II, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.

Patients and healthcare providers should stop using the affected Levothyroxine Sodium tablets and contact their pharmacist or physician for a replacement. Consumers should check their medication packaging for the NDC 00378180701 and the specific pedigree codes listed in the recall notice to determine if their medication is affected.

The recalled product

Product
LEVOTHYROXINE SODIUM, Tablet, 88 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378180701.
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 (12)

  • LEVOTHYROXINE SODIUM
  • Tablet
  • 88 mcg has the following codes: Pedigree: AD73652_10
  • EXP: 5/30/2014
  • Pedigree: W003047
  • EXP: 6/12/2014
  • Pedigree: W003476
  • EXP: 6/20/2014
  • Pedigree: W002967
  • EXP: 6/11/2014
  • Pedigree: AD42584_1
  • EXP: 5/14/2014.

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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