The Recall Desk
ModerateFDA (Drugs)·D-1002-2014·Announced 2014-01-29

Aidapak Recalls Imipramine Tablets Due to Potential Label Mixup

Aidapak Services, LLC is recalling Imipramine HCL 25 mg tablets because they may have been mislabeled as Fenofibrate 54 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, which corresponds to a Moderate severity score under the rubric for minor labeling errors or low-risk contamination without reported serious injury.

Plain-English summary

Aidapak Services, LLC is recalling Imipramine HCL, Tablet, 25 mg, NDC 00781176401, due to a potential label mixup. The recalled product may have been mislabeled as Fenofibrate, Tablet, 54 mg, NDC 00115551110. The specific pedigree for the recalled Imipramine is AD49448_10, with an expiration date of 5/17/2014.

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The recall is classified as Class II by the FDA, indicating a situation where 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 Imipramine HCL 25 mg tablets with pedigree AD49448_10 and expiration date 5/17/2014. If found, these products should be quarantined and returned to the distributor or manufacturer for further instructions.

The recalled product

Product
IMIPRAMINE HCL, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781176401.
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)

  • IMIPRAMINE HCL
  • Tablet
  • 25 mg has the following codes: Pedigree: AD49448_10
  • EXP: 5/17/2014.

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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