Sertraline HCL Tablet recall: Labeling Error
SERTRALINE HCL Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714061204
Why was Sertraline HCL Tablet 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,
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
SERTRALINE HCL Tablet, 50 mg has the following codes Pedigree: AD70585_7, EXP: 5/29/2014; Pedigree: W003575, EXP: 6/24/2014; Pedigree: AD46426_1, EXP: 5/15/2014; Pedigree: AD30993_14, EXP: 5/9/2014; Pedigree: W003033, EXP: 6/12/2014.
- Product
- SERTRALINE HCL Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714061204
- Recalling firm
- Aidapak Services, LLC
- Quantity
- 500 Tablets
- Distribution
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
- Recall date
- January 22, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)