DULoxetine HCl DR recall: Labeling Error
DULoxetine HCl DR, Capsule, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002323560.
Why was DULoxetine HCl DR recalled?
Labeling: Label Mixup: DULoxetine HCl DR, Capsule, 20 mg, may be potentially mis-labeled with one of the following drugs: ENTECAVIR, Tablet, 0.5 mg, NDC 00003161112, Pedigree: AD30140_28, EXP: 5/7/2014; CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD54587_1, EXP: 5/21/2014; FLUoxetine HCl, Capsule, 10 mg , NDC 16714035103, Pedigree: AD70585_13, EXP: 5/29/2014; CHOLECALCIFEROL
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- DULoxetine HCl DR, Capsule, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002323560.
- Recalling firm
- Aidapak Services, LLC
- Quantity
- 600 Capsules
- Distribution
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
- Recall date
- January 29, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)