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

Recall Number: D-559-2014

Firm: Aidapak Services, LLC

Classification: Class II

Status: Terminated

Report Date: 20140122

Initiation Date: 20130702

Termination Date: 20140207

Reason for Recall

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.

Product Description

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