Status
Terminated
Drug Enforcement D-508-2014
Labeling: Label Mixup; lamotrigine, Tablet, 50 mg (1/2 of 100 mg) may be potentially mislabeled as OXYBUTYNIN CHLORIDE, Tablet, 2.5 mg (1/2 of 5 mg), NDC 00603497521, Pedigree: AD73525_64, EXP: 5/30/2014; FEXOFENADINE HCL, Tablet, 60 mg, NDC 45802042578, Pedigree: AD46257_50, EXP: 5/15/2014.
Classification
Class II
Report Date
January 22, 2014
Termination Date
February 7, 2014
Product Information
- Product description
- lamoTRIgine, Tablet, 50 mg (1/2 of 100 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 13668004701
- Product quantity
- 600 Tablets
- Reason for recall
- Labeling: Label Mixup; lamotrigine, Tablet, 50 mg (1/2 of 100 mg) may be potentially mislabeled as OXYBUTYNIN CHLORIDE, Tablet, 2.5 mg (1/2 of 5 mg), NDC 00603497521, Pedigree: AD73525_64, EXP: 5/30/2014; FEXOFENADINE HCL, Tablet, 60 mg, NDC 45802042578, Pedigree: AD46257_50, EXP: 5/15/2014.
- 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-508-2014
- Event ID
- 65707
- Recall initiation date
- July 2, 2013
- Center classification date
- January 16, 2014
- Code info
- lamoTRIgine, Tablet, 50 mg (1/2 of 100 mg) has the following codes Pedigree: ADWA00002116, EXP: 5/31/2014; Pedigree: AD46265_31, EXP: 5/15/2014.
- More code info
- —