FDAFDA · Food and drugs·Recall number D-684-2014
guaiFENesin ER Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63824000850
Published January 22, 2014 · Recall initiated: July 2, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Aidapak Services, LLC
- Distributor
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
- Lot
- guaiFENesin ER, Tablet, 600 mg has the following code Pedigree: W003244, EXP: 6/17/2014.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States