The Recall Desk
SevereFDA (Drugs)·D-711-2014·Announced 2014-01-22

Aidapak Recalls Guanfacine Tablets Due to Potential Label Mixup

Aidapak Services, LLC is recalling guanfacine HCl tablets because they may be mislabeled as other prescription medications.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a significant hazard such as a label mixup that could lead to the administration of the wrong medication corresponds to a severity score of 4 (Severe).

Plain-English summary

Aidapak Services, LLC is recalling guanfacine HCl tablets, 2 mg, NDC 65162071310, due to a labeling mixup. The source text indicates that these tablets may be potentially mislabeled as other prescription drugs, including bupropion HCl ER, amantadine HCl, glyburide, and acyclovir.

The recalled product consists of 501 tablets. The repacked drugs were distributed in Arizona, California, Oregon, and Washington. Specific pedigree codes and expiration dates associated with the recall include AD21790_13 (EXP: 5/1/2014), W002999 (EXP: 6/11/2014), W003678 (EXP: 6/25/2014), and AD60272_10 (EXP: 5/22/2014).

Consumers and healthcare providers should check their inventory for these specific NDC numbers and pedigree codes. 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
guanFACINE HCl Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65162071310
Affected units
501

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
  • 2 mg has the following codes Pedigree: AD21790_13
  • EXP: 5/1/2014
  • Pedigree: W002999
  • EXP: 6/11/2014
  • Pedigree: W003678
  • EXP: 6/25/2014
  • Pedigree: AD60272_10
  • EXP: 5/22/2014.

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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