Recalls / Class II
Class IID-526-2014
Product
hydrALAZINE HCl Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23155000401
- Affected lot / code info
- hydrALAZINE HCl Tablet, 100 mg has the following codes Pedigree: AD46312_13, EXP: 5/16/2014; Pedigree: AD73652_4, EXP: 5/29/2014; Pedigree: AD30197_7, EXP: 5/9/2014.
Why it was recalled
Labeling: Label Mixup; hydrALAZINE HCl Tablet, 100 mg may be potentially mislabeled as DOXEPIN HCL, Capsule, 150 mg, NDC 49884022201, Pedigree: AD46312_10, EXP: 5/16/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375701, Pedigree: AD73652_1, EXP: 5/29/2014; LEVOTHYROXINE SODIUM, Tablet, 112 mcg, NDC 00378181101, Pedigree: AD30197_13, EXP: 5/9/2014.
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-526-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.