Recalls / Class II
Class IID-592-2014
Product
traZODone HCl Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 50111043301
- Affected lot / code info
- traZODone HCl, Tablet, 50 mg has the following codes Pedigree: AD37088_4, EXP: 5/9/2014; Pedigree: AD54562_1, EXP: 5/20/2014; Pedigree: AD39611_4, EXP: 5/14/2014.
Why it was recalled
Labeling: Label Mixup; traZODone HCl Tablet, 50 mg may be potentially mislabeled as DEXAMETHASONE, Tablet, 1 mg, NDC 00054418125, Pedigree: AD37088_1, EXP: 5/9/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375701, Pedigree: AD54498_4, EXP: 5/20/2014; guanFACINE HCl, Tablet, 1 mg, NDC 00591044401, Pedigree: AD39611_1, EXP: 4/30/2014.
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 400 Tablets
- Distribution pattern
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Timeline
- Recall initiated
- 2013-07-02
- FDA classified
- 2014-01-16
- Posted by FDA
- 2014-01-22
- Terminated
- 2014-02-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-592-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.