Recalls / Class II
Class IID-619-2014
Product
OLANZapine Tablet, 7.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 55111016530
- Affected lot / code info
- OLANZapine, Tablet, 7.5 mg has the following codes Pedigree: AD46265_46, EXP: 5/15/2014; Pedigree: AD60272_79, EXP: 5/22/2014; Pedigree: AD73525_58, EXP: 5/30/2014.
Why it was recalled
Labeling:Label Mixup; OLANZapine, Tablet, 7.5 mg may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 175 mcg, NDC 00527135001, Pedigree: AD46265_37, EXP: 5/15/2014; LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00781518392, Pedigree: AD60272_73, EXP: 5/22/2014; MIRTAZAPINE, Tablet, 7.5 mg, NDC 59762141503, Pedigree: AD73525_55, EXP: 5/30/2014.
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 210 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-619-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.