The Recall Desk
ModerateFDA (Drugs)·D-584-2014·Announced 2014-01-22

Nicotine Polacrilex Lozenges Recalled for Potential Labeling Mixup

Aidapak Services is recalling 2 mg Nicotine Polacrilex Lozenges because they may be mislabeled as Vitamin B Complex 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 error (mislabeling) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Aidapak Services, LLC is recalling 70-count boxes of NICOTINE POLACRILEX Lozenge, 2 mg, Rx only (NDC 49348085216). The recall is due to a labeling mixup where the product may be potentially mislabeled as VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet (NDC 60258016001).

The affected product has the pedigree W003393 and an expiration date of 6/19/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Consumers should check their medication for the specific NDC and pedigree listed above. If the product is found, it should be returned to the pharmacy or healthcare provider for replacement or refund.

The recalled product

Product
NICOTINE POLACRILEX Lozenge, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 49348085216
Affected units
70

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 (4)

  • NICOTINE POLACRILEX
  • Lozenge
  • 2 mg has the following code Pedigree: W003393
  • EXP: 6/19/2014.

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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