Recalls / Class II
Class IID-645-2014
Product
MIRTAZAPINE Tablet, 7.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762141503
- Affected lot / code info
- MIRTAZAPINE, Tablet, 7.5 mg has the following codes Pedigree: AD73525_55, EXP: 5/30/2014; Pedigree: W003012, EXP: 6/11/2014; Pedigree: W003334, EXP: 6/18/2014.
Why it was recalled
Labeling:Label Mixup; MIRTAZAPINE Tablet, 7.5 mg may be potentially mislabeled as BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg, NDC 00574010603, Pedigree: AD73525_40, EXP: 5/30/2014; DULoxetine HCl DR, Capsule, 20 mg, NDC 00002323560, Pedigree: W003005, EXP: 6/11/2014; carBAMazepine ER, Tablet, 100 mg, NDC 00078051005, Pedigree: W003330, EXP: 6/18/2014.
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 91 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-645-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.