FDA-Drug2014-01-22Class II

SERTRALINE HCL Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714061204

Aidapak Services, LLC
Hazard

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,

Sold states
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Affected count
500 Tablets
Manufactured in
14301 Se 1st St, Vancouver, WA, United States
Products
SERTRALINE HCL Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714061204

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-523-2014

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