Recalls / Class II
Class IID-986-2014
Product
MODAFINIL, Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603466216.
- Affected lot / code info
- MODAFINIL, Tablet, 200 mg has the following codes: Pedigree: W002760, EXP: 6/6/2014; Pedigree: W003779, EXP: 6/26/2014.
Why it was recalled
Labeling: Label Mixup: MODAFINIL, Tablet, 200 mg may have potentially been mislabeled as one of the following drugs: OMEGA-3-ACID ETHYL ESTERS, Capsule, 1000 mg, NDC 00173078302, Pedigree: W003692, EXP: 6/26/2014.
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 60 Tablets
- 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-986-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.