The Recall Desk
HighFDA (Drugs)·D-965-2014·Announced 2014-01-29

Aidapak Recalls Guanfacine Tablets Due to Potential Label Mixup

Aidapak Services, LLC is recalling guanfacine HCl tablets because they may have been mislabeled as other prescription drugs.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a label mixup that could result in patients receiving incorrect prescription medications, posing a risk of harm.

Plain-English summary

Aidapak Services, LLC is recalling guanfacine HCl tablets, 1 mg, NDC 00591044401, due to a potential labeling error. The recall involves 500-tablet units that were repacked and distributed in Arizona, California, Oregon, and Washington.

The FDA has identified a label mixup where the guanfacine tablets may have been mislabeled as other medications, including bupropion HCl ER, omega-3 fatty acid, or omeprazole/sodium bicarbonate. This error could lead to patients receiving the wrong medication.

Patients and healthcare providers should check their inventory for the specific pedigree codes and expiration dates listed in the recall notice. If the product is found, it should be returned to the distributor or the FDA should be contacted for further instructions.

The recalled product

Product
guanFACINE HCl, Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591044401.
Affected units
500

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 (9)

  • guanFACINE HCl
  • Tablet
  • 1 mg has the following codes: Pedigree: W002728
  • EXP: 4/30/2014
  • Pedigree: AD39611_1
  • Pedigree: W003791
  • EXP: 6/27/2014
  • Pedigree: AD73525_13
  • EXP: 4/30/2014.

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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