AuroMedics Recalls Mirtazapine Tablets Due to Labeling Error
AuroMedics Pharma LLC is recalling Mirtazapine 15 mg tablets because some 500-count bottles are incorrectly labeled as 7.5 mg tablets.
What this means for you
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 I, but the hazard is a labeling error regarding strength, which typically falls under moderate severity for minor labeling errors unless specific harm is reported.
Plain-English summary
AuroMedics Pharma LLC is recalling Mirtazapine Tablets, USP, 15 mg, 500-count bottles. The recall is due to a labeling error where some bottles containing 15 mg tablets are labeled as Mirtazapine 7.5 mg tablets.
The affected product is distributed by Aurobindo Pharma USA, Inc. in Dayton, NJ, and is identified by NDC 13107-031-05. The specific lot number is 03119002A3, with an expiration date of 3/2022. The distribution pattern is nationwide.
Consumers should check their medication bottles for the specific lot number and expiration date. If the product matches the description, they should contact their healthcare provider or pharmacist for guidance on how to proceed.
The recalled product
- Product
- MIRTAZAPINE (MIRTAZAPINE)
- Brand
- MIRTAZAPINE
- Manufacturer
- AuroMedics Pharma LLC
- Category
- Drug — Prescription Medication
- Hazard
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 (2)
- Lot #: 03119002A3
- Exp 3/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by AuroMedics Pharma 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.
See all 2 products in this recall →Related recalls
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