AuroMedics Recalls Mirtazapine Tablets Due to Labeling Error
AuroMedics Pharma LLC is recalling Mirtazapine 15 mg tablets that were incorrectly labeled as 7.5 mg. The error affects 500-count bottles distributed nationwide.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of at least 4 per the rubric, as it poses a reasonable probability of serious adverse health consequences or death due to potential dosing errors.
Plain-English summary
AuroMedics Pharma LLC is recalling specific bottles of Mirtazapine Tablets, USP, 15 mg. The recall is due to a labeling error where the bottles contain 15 mg tablets but are labeled as 7.5 mg tablets.
The affected product is distributed by Aurobindo Pharma USA, Inc. in Dayton, NJ. 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 lot number 03119002A3 and the incorrect 7.5 mg label on 15 mg tablets. If found, they should stop using the product and contact their healthcare provider or pharmacist for guidance.
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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