The Recall Desk
ModerateFDA (Drugs)·D-840-2014·Announced 2014-01-29

FDA Recalls Nefazodone Tablets Due to Potential Labeling Error

Aidapak Services is recalling Nefazodone HCL 150 mg tablets because they may have been mislabeled as Liothyronine Sodium 25 mcg.

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 illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Aidapak Services, LLC is recalling Nefazodone HCL, Tablet, 150 mg (NDC 00093711306) due to a potential labeling error. The recalled product may have been mislabeled as Liothyronine Sodium, Tablet, 25 mcg (NDC 42794001902). The specific pedigree for the recalled Nefazodone is AD46414_41, with an expiration date of 5/16/2014.

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The recall is classified as FDA Class II, indicating a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.

Consumers who have this product should contact their healthcare provider or pharmacist for guidance. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
NEFAZODONE HCL, Tablet, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093711306.
Affected units
60

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)

  • NEFAZODONE HCL
  • Tablet
  • 150 mg has the following codes: Pedigree: AD46414_41
  • 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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