Status
Terminated
Drug Enforcement D-623-2014
Labeling:Label Mixup; MODAFINIL Tablet, 50 mg (1/2 of 100 mg Tablet) may be potentially mislabeled as SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg, NDC 00414200007, Pedigree: AD21859_1, EXP: 10/31/2013.
Classification
Class II
Report Date
January 22, 2014
Termination Date
February 7, 2014
Product Information
- Product description
- MODAFINIL Tablet, 50 mg (1/2 of 100 mg Tablet), Rx only, Distributed by: AidaPak Service, LLC, NDC 55253080130
- Product quantity
- 60 Tablets
- Reason for recall
- Labeling:Label Mixup; MODAFINIL Tablet, 50 mg (1/2 of 100 mg Tablet) may be potentially mislabeled as SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg, NDC 00414200007, Pedigree: AD21859_1, EXP: 10/31/2013.
- 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-623-2014
- Event ID
- 65707
- Recall initiation date
- July 2, 2013
- Center classification date
- January 16, 2014
- Code info
- MODAFINIL Tablet, 50 mg (1/2 of 100 mg Tablet) has the following code Pedigree: AD21787_4, EXP: 5/1/2014.
- More code info
- —