The Recall Desk
ModerateFDA (Drugs)·D-899-2014·Announced 2014-01-29

Levothyroxine Sodium Tablets Recalled for Potential Label Mixup

Aidapak Services is recalling Levothyroxine Sodium tablets that may have been mislabeled as Pramipexole Di-HCl.

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 due to a labeling error (label mixup) which is a minor labeling error with no reported injuries or illnesses, fitting the Moderate severity criteria.

Plain-English summary

Aidapak Services, LLC is recalling Levothyroxine Sodium, Tablet, 175 mcg (NDC 00378181701) due to a potential label mixup. The recalled product may have been mislabeled as Pramipexole Di-HCl, Tablet, 1 mg (NDC 16714058701). The specific pedigree for the recalled Levothyroxine Sodium is W003151, with an expiration date of 6/13/2014.

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The agency has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers and healthcare providers should check their inventory for Levothyroxine Sodium tablets with pedigree W003151 and expiration date 6/13/2014. If found, these products should be quarantined and returned to the distributor or manufacturer for further instructions.

The recalled product

Product
LEVOTHYROXINE SODIUM, Tablet, 175 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378181701
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
  • 175 mcg has the following codes: Pedigree: W003151
  • EXP: 6/13/2014.

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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