The Recall Desk
ModerateFDA (Drugs)·D-593-2014·Announced 2014-01-22

Trazodone HCl Tablets Recalled Due to Potential Labeling Error

Aidapak Services, LLC is recalling Trazodone HCl 50 mg tablets because they may be mislabeled as Amantadine HCl 100 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 due to a labeling error (label mixup) which is a minor labeling error with no reported illnesses or injuries, fitting the Moderate severity criteria.

Plain-English summary

Aidapak Services, LLC is recalling Trazodone HCl Tablet, 50 mg, Rx only, NDC 50111043303. The recall is due to a labeling error where the product may be mislabeled as AMANTADINE HCL, Tablet, 100 mg, NDC 00832011100. The affected product has the pedigree AD54475_7 and an expiration date of 5/20/2014.

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 Trazodone HCl 50 mg tablets with the specified pedigree and expiration date. If the product is found, it should be returned to the distributor or disposed of according to local regulations. Patients should consult their healthcare provider if they have questions about their medication.

The recalled product

Product
traZODone HCl Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 50111043303
Affected units
2,000

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)

  • traZODone HCl
  • Tablet
  • 50 mg has the following code Pedigree: AD54475_7
  • EXP: 5/20/2014.

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 273 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 273 products in this recall →

Same manufacturer · Aidapak Services, LLC

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