The Recall Desk
ModerateFDA (Drugs)·D-683-2014·Announced 2014-01-22

Aidapak Recalls GuaiFENesin ER Tablets Due to Labeling Mixup

Aidapak Services, LLC is recalling guaiFENesin ER tablets because they may be mislabeled as prenatal multivitamin or other medications.

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 mixup, which fits the rubric for moderate severity involving minor labeling errors or low-risk contamination.

Plain-English summary

Aidapak Services, LLC is recalling guaiFENesin ER tablets, 600 mg, because the product may be potentially mislabeled. The recall involves tablets that could be incorrectly identified as PRENATAL MULTIVITAMIN/MULTIMINERAL, diphenhydrAMINE HCl, or DOCUSATE SODIUM.

The affected product is guaiFENesin ER, Tablet, 600 mg, NDC 6382400834. The source text lists specific pedigree codes and expiration dates for the recalled units, including AD62834_4, AD62834_7, W003514, W003574, W003850, W003931, AD46429_1, and AD73592_1. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Consumers should check their medication labels and stop using the product if it matches the recalled description. They should contact their healthcare provider or pharmacist for guidance on proper medication management.

The recalled product

Product
guaiFENesin ER Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63824000834
Affected units
480

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 (17)

  • guaiFENesin ER
  • Tablet
  • 600 mg has the following codes Pedigree: AD62834_4
  • EXP: 5/24/2014
  • Pedigree: AD62834_7
  • Pedigree: W003514
  • EXP: 6/21/2014
  • Pedigree: W003574
  • EXP: 6/24/2014
  • Pedigree: W003850
  • EXP: 6/27/2014
  • Pedigree: W003931
  • EXP: 6/28/2014
  • Pedigree: AD46429_1
  • EXP: 5/15/2014
  • Pedigree: AD73592_1
  • EXP: 5/31/2014.

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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