Aidapak Recalls Nicotine Polacrilex Lozenges Due to Potential Labeling Errors
Aidapak Services is recalling 2 mg nicotine polacrilex lozenges because they may have been mislabeled as other prescription drugs. The affected products were distributed in four western states.
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, which typically involves a labeling error that could lead to temporary or medically reversible health consequences. The rubric assigns a score of 2 to minor labeling errors and voluntary precautionary recalls.
Plain-English summary
Aidapak Services, LLC is recalling 2 mg nicotine polacrilex lozenges (NDC 00135051001) due to a potential labeling error. The recall was initiated because the nicotine lozenges may have been mislabeled as other prescription medications, including estradiol tablets, acamprosate calcium tablets, calcitriol capsules, and eszopiclone tablets.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The source text lists specific pedigree codes and expiration dates for the affected nicotine lozenges, ranging from May 1, 2014, to June 26, 2014.
Consumers and healthcare providers should check their inventory for the specific NDC and pedigree codes listed in the recall notice. If the product matches the description, it should be returned to the distributor or disposed of according to local regulations. Patients should consult their healthcare provider if they have questions about their medication.
The recalled product
- Product
- NICOTINE POLACRILEX, LOZENGE, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00135051001.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 1,216
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 (14)
- NICOTINE POLACRILEX
- LOZENGE
- 2 mg has the following codes: Pedigree: AD32973_7
- EXP: 5/9/2014
- Pedigree: W002974
- EXP: 6/11/2014
- Pedigree: W003749
- EXP: 6/26/2014
- Pedigree: W002766
- EXP: 6/6/2014
- Pedigree: AD21858_1
- EXP: 5/1/2014
- Pedigree: AD46333_10
- EXP: 5/16/2014.
Distribution
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.
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