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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- 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
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.
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