FDAFDA · Food and drugs·Recall number D-1013-2014
AMANTADINE HCL, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00832011100.
Published January 29, 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: AMANTADINE HCL, Tablet, 100 mg may have potentially been mislabeled as one of the following drugs: MAGNESIUM CHLORIDE, Tablet, 64 mg, NDC 68585000575, Pedigree: AD52993_4, EXP: 5/17/2014; QUEtiapine FUMARATE, Tablet, 25 mg, NDC 65862048901, Pedigree: AD49582_22, EXP: 4/30/2014.
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
- AMANTADINE HCL, Tablet, 100 mg has the following codes: Pedigree: AD54475_1, EXP: 5/20/2014; Pedigree: AD54475_4, EXP: 5/20/2014.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States