Recalls / Class II
Class IID-765-2014
Product
ATOMOXETINE HCL, Capsule, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002322930.
- Affected lot / code info
- ATOMOXETINE HCL, Capsule, 40 mg has the following codes: Pedigree: AD21790_82, EXP: 5/1/2014; Pedigree: AD46265_52, EXP: 5/15/2014; Pedigree: AD60272_89, EXP: 5/22/2014; Pedigree: AD73525_67, EXP: 5/30/2014; Pedigree: W003014, EXP: 6/11/2014.
Why it was recalled
Labeling: Label Mixup: ATOMOXETINE HCL, Capsule, 40 mg may be potentially mis-labeled as OLANZAPINE, Tablet, 7.5 mg, NDC 60505311203, Pedigree: AD21790_76, EXP: 5/1/2014; ARIPiprazole, Tablet, 2 mg, NDC 59148000613, Pedigree: AD46265_19, EXP: 5/15/2014; OLANZapine, Tablet, 7.5 mg, NDC 55111016530, Pedigree: AD60272_79, EXP: 5/22/2014; OLANZapine, Tablet, 7.5 mg, NDC 55111016530, Pedigree: AD73
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 180 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-765-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.