Aidapak Recalls Duloxetine Capsules Due to Potential Labeling Errors
Aidapak Services, LLC is recalling Duloxetine HCl DR capsules because they may be mislabeled with other medications. The repacked drugs 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 and involves a labeling error (label mixup) without reported illnesses, fitting the criteria for minor labeling errors or low-risk contamination.
Plain-English summary
Aidapak Services, LLC is recalling 600-capsule bottles of Duloxetine HCl DR, 20 mg, because the product may be potentially mislabeled with other drugs. The recall involves specific pedigree codes and expiration dates ranging from May 1, 2014, to June 21, 2014.
The mislabeling risk involves the Duloxetine capsules being confused with Entecavir, Calcium Acetate, Fluoxetine HCl, or Cholecalciferol. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Consumers who have these specific products should stop using them and contact their healthcare provider or pharmacist for instructions on how to dispose of the medication or obtain a replacement.
The recalled product
- Product
- DULoxetine HCl DR, Capsule, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002323560.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 600
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 (18)
- DULoxetine HCl DR
- Capsule
- 20 mg has the following codes: Pedigree: AD30140_31
- EXP: 5/7/2014
- Pedigree: AD54587_4
- EXP: 5/21/2014
- Pedigree: AD70585_16
- EXP: 5/29/2014
- Pedigree: W003506
- EXP: 6/21/2014
- Pedigree: AD60272_61
- EXP: 5/22/2014
- Pedigree: AD21790_49
- EXP: 5/1/2014
- Pedigree: W003005
- EXP: 6/11/2014
- Pedigree: W003486
- EXP: 6/20/2014.
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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