SERTRALINE HCL Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714061204
Reported: January 22, 2014 Initiated: July 2, 2013 #D-523-2014
Product Description
SERTRALINE HCL Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714061204
Reason for Recall
Labeling: Label Mixup; SERTRALINE HCL Tablet, 50 mg may be potentially mislabeled as NORTRIPTYLINE HCL, Capsule, 10 mg, NDC 00093081001, Pedigree: AD70585_4, EXP: 5/29/2014; guaiFENesin ER, Tablet, 600 mg, NDC 63824000834, Pedigree: W003574, EXP: 6/24/2014; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,110 mg, NDC 11523726503, Pedigree: AD46300_17, EXP: 5/15/2014; CHOLECALCIFEROL, Tablet,
Details
- Recalling Firm
- Aidapak Services, LLC
- Units Affected
- 500 Tablets
- Distribution
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
- Location
- Vancouver, WA
Frequently Asked Questions
What product was recalled? ▼
SERTRALINE HCL Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714061204. Recalled by Aidapak Services, LLC. Units affected: 500 Tablets.
Why was this product recalled? ▼
Labeling: Label Mixup; SERTRALINE HCL Tablet, 50 mg may be potentially mislabeled as NORTRIPTYLINE HCL, Capsule, 10 mg, NDC 00093081001, Pedigree: AD70585_4, EXP: 5/29/2014; guaiFENesin ER, Tablet, 600 mg, NDC 63824000834, Pedigree: W003574, EXP: 6/24/2014; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,110 mg, NDC 11523726503, Pedigree: AD46300_17, EXP: 5/15/2014; CHOLECALCIFEROL, Tablet,
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 22, 2014. Severity: Moderate. Recall number: D-523-2014.
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