Status
Terminated
Drug Enforcement D-684-2014
Labeling:Label Mixup; guaiFENesin ER Tablet, 600 mg may be potentially mislabeled as OMEGA-3-ACID ETHYL ESTERS, Capsule, 1000 mg, NDC 00173078302, Pedigree: W003243, EXP: 6/17/2014.
Classification
Class II
Report Date
January 22, 2014
Termination Date
February 7, 2014
Product Information
- Product description
- guaiFENesin ER Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63824000850
- Product quantity
- 500 Tablets
- Reason for recall
- Labeling:Label Mixup; guaiFENesin ER Tablet, 600 mg may be potentially mislabeled as OMEGA-3-ACID ETHYL ESTERS, Capsule, 1000 mg, NDC 00173078302, Pedigree: W003243, EXP: 6/17/2014.
- 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-684-2014
- Event ID
- 65707
- Recall initiation date
- July 2, 2013
- Center classification date
- January 16, 2014
- Code info
- guaiFENesin ER, Tablet, 600 mg has the following code Pedigree: W003244, EXP: 6/17/2014.
- More code info
- —