Aidapak Recalls Varenicline Tablets Due to Potential Labeling Errors
Aidapak Services, LLC is recalling Varenicline 0.5 mg tablets because they may have been mislabeled as other prescription drugs. The recall covers specific lots 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 and involves a labeling error (label mixup) without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Aidapak Services, LLC is recalling Varenicline 0.5 mg tablets (NDC 00069046856) due to a potential label mixup. The FDA has identified that these tablets may have been incorrectly labeled as Lactobacillus GG capsules, Sotalol HCl tablets, or Venlafaxine HCl tablets. This labeling error could result in patients receiving the wrong medication.
The recalled product consists of 168-tablet packages of Varenicline 0.5 mg. The specific lots affected include pedigree W003083 (expiration 6/12/2014), pedigree AD22616_1 (expiration 5/2/2014), and pedigree AD62829_1 (expiration 5/22/2014). These repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Patients and healthcare providers should check their medication labels and lot numbers against the recalled list. If the product matches the recalled description, it should be returned to the pharmacy or contact Aidapak Services, LLC for instructions. Do not take the medication if there is any uncertainty regarding the label or lot number.
The recalled product
- Product
- VARENICLINE, Tablet, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00069046856.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 168
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 (8)
- VARENICLINE
- Tablet
- 0.5 mg has the following codes: Pedigree: W003083
- EXP: 6/12/2014
- Pedigree: AD22616_1
- EXP: 5/2/2014
- Pedigree: AD62829_1
- EXP: 5/22/2014.
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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