Recalls / Class II
Class IID-766-2014
Product
DULoxetine HCl DR, Capsule, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002323560.
- Affected lot / code info
- 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.
Why it was 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
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 600 Capsules
- Distribution pattern
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Timeline
- Recall initiated
- 2013-07-02
- FDA classified
- 2014-01-20
- Posted by FDA
- 2014-01-29
- Terminated
- 2014-02-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-766-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.