Nicotine Polacrilex Lozenges Recalled for Potential Label Mixup
Aidapak Services is recalling 1,582 Nicotine Polacrilex Lozenges because they may be mislabeled as other prescription drugs.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a potential label mixup on prescription drugs, which poses a risk of incorrect medication administration. This aligns with the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Aidapak Services, LLC is recalling 1,582 units of NICOTINE POLACRILEX Lozenge, 2 mg, Rx only, NDC 37205098769. The recall is due to a labeling error where the product may be mislabeled as other medications, including Aspirin, Chlorpromazine, Calcium Acetate, and Folic Acid.
The affected repacked drugs were distributed in Arizona, California, Oregon, and Washington. The source text lists specific pedigree codes and expiration dates for the affected lots, including AD52433_4, AD70700_4, AD73623_7, W003823, and W003463.
Consumers should check their medication packaging for the NDC 37205098769 and the specific pedigree codes listed in the recall notice. If the product matches the description, patients should contact their healthcare provider or pharmacist for guidance on proper disposal or replacement.
The recalled product
- Product
- NICOTINE POLACRILEX Lozenge, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 37205098769
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 1,582
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 (11)
- NICOTINE POLACRILEX Lozenge
- 2 mg has the following codes Pedigree: AD52433_4
- EXP: 5/17/2014
- Pedigree: AD70700_4
- EXP: 5/29/2014
- Pedigree: AD73623_7
- EXP: 5/30/2014
- Pedigree: W003823
- EXP: 6/27/2014
- Pedigree: W003463
- EXP: 6/20/2014.
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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