The Recall Desk
ModerateFDA (Drugs)·D-829-2014·Announced 2014-01-29

Aidapak Recalls Nortriptyline Capsules Due to Potential Label Mixup

Aidapak Services, LLC is recalling Nortriptyline HCL capsules because they may have been mislabeled as other medications. The affected drugs were distributed in four western states.

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 (label mixup) without reported injuries or illnesses, fitting the criteria for moderate severity.

Plain-English summary

Aidapak Services, LLC is recalling Nortriptyline HCL, Capsule, 75 mg, NDC 00093081301, due to a potential label mixup. The recall involves 100-capsule bottles of the prescription medication that may have been incorrectly labeled as guaiFENesin ER, Tablet, 600 mg, or Mirtazapine, Tablet, 7.5 mg.

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The affected lots include pedigree AD21790_73 with an expiration date of 5/1/2014, and pedigree W003694 with an expiration date of 6/26/2014. The FDA has classified this as a Class II recall.

Patients and healthcare providers should check their medication labels to ensure they are taking the correct drug. If you have medication with the specific pedigree and expiration dates listed above, contact your pharmacist or healthcare provider for instructions on how to proceed.

The recalled product

Product
NORTRIPTYLINE HCL, Capsule, 75 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093081301.
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 (6)

  • NORTRIPTYLINE HCL
  • Capsule
  • 75 mg has the following codes: Pedigree: AD21790_73
  • EXP: 5/1/2014
  • Pedigree: W003694
  • EXP: 6/26/2014.

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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