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FDAFDA · Food and drugs·Recall number D-559-2014

HYOSCYAMINE SULFATE ER, Tablet, 0.375 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 43199001401

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; HYOSCYAMINE SULFATE ER Tablet, 0.375 mg may be potentially mislabeled as SERTRALINE HCL, Tablet, 50 mg, NDC 16714061204, Pedigree: W003575, EXP: 6/24/2014.

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
HYOSCYAMINE SULFATE ER Tablet, 0.375 mg has the following code Pedigree: W003576, EXP: 6/24/2014.
Risk classification
Class II
Area (FDA)
drug
Country
United States

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