D-559-2014 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 22, 2014
- Initiation Date
- July 2, 2013
- Termination Date
- February 7, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 99 Tablets
Product Description
HYOSCYAMINE SULFATE ER, Tablet, 0.375 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 43199001401
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.
Distribution Pattern
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Code Information
HYOSCYAMINE SULFATE ER Tablet, 0.375 mg has the following code Pedigree: W003576, EXP: 6/24/2014.