The Recall Desk
ModerateFDA (Drugs)·D-925-2014·Announced 2014-01-29

Nicotine Polacrilex Gum Recalled for Potential Labeling Mixup

Aidapak Services, LLC is recalling 2 mg Nicotine Polacrilex Gum due to a potential labeling mixup with Folic Acid or Quetiapine Fumarate tablets.

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 criterion for minor labeling errors or low-risk contamination.

Plain-English summary

Aidapak Services, LLC is recalling 1,210 pieces of Nicotine Polacrilex Gum, 2 mg, NDC 00536302923. The recall is due to a labeling mixup where the nicotine gum may have been mislabeled as Folic Acid, Tablet, 1 mg, or Quetiapine Fumarate, Tablet, 25 mg.

The affected repacked drugs were distributed in Arizona, California, Oregon, and Washington. The recall involves specific pedigree codes AD33897_28 (expiration 2/28/2014) and W003100 (expiration 6/13/2014).

Consumers should check their medication for these specific NDC and pedigree codes. If the product matches the description, they should stop using it and contact their healthcare provider or pharmacist for guidance.

The recalled product

Product
NICOTINE POLACRILEX, GUM, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00536302923.
Affected units
1,210

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)

  • NICOTINE POLACRILEX
  • GUM
  • 2 mg has the following codes: Pedigree: AD33897_28
  • EXP: 2/28/2014
  • Pedigree: W003100
  • EXP: 6/13/2014.

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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