Sertraline HCL Tablets Recalled for Potential Labeling Errors
Aidapak Services is recalling Sertraline HCL 50 mg tablets because they may be mislabeled as other medications. The repacked drugs were distributed in four western states.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling mixup. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries fall under the Moderate severity level.
Plain-English summary
Aidapak Services, LLC is recalling Sertraline HCL Tablet, 50 mg, Rx only, NDC 16714061204. The recall is due to a labeling mixup where the product may be potentially mislabeled as other medications, including Nortriptyline HCL, Guaifenesin ER, Omeprazole/Sodium Bicarbonate, and Cholecalciferol.
The affected repacked drugs were distributed in Arizona, California, Oregon, and Washington. The source text lists specific pedigree codes and expiration dates for the recalled units, including AD70585_7, W003575, AD46426_1, AD30993_14, and W003033.
Consumers should check their medication packaging against the specific NDC and pedigree codes listed in the official recall notice. If the product matches the recalled description, they should contact their pharmacist or healthcare provider for guidance on proper disposal or replacement.
The recalled product
- Product
- SERTRALINE HCL Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714061204
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 500
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- 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.
Distribution
Part of a larger recall action
This product is one of 273 recalled by Aidapak Services, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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