Status
Terminated
Drug Enforcement D-619-2014
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.
Classification
Class II
Report Date
January 22, 2014
Termination Date
February 7, 2014
Product Information
- Product description
- OLANZapine Tablet, 7.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 55111016530
- Product quantity
- 210 Tablets
- Reason for recall
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Telephone
- Distribution pattern
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Location & Firm
- Recalling firm
- Aidapak Services, LLC
- Address
-
14301 Se 1st St
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-619-2014
- Event ID
- 65707
- Recall initiation date
- July 2, 2013
- Center classification date
- January 16, 2014
- 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.
- More code info
- —