The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0636-2020·Announced 2019-12-18

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.

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 classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets."

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

Same brand · MIRTAZAPINE

Same manufacturer · AuroMedics Pharma LLC

See all →

Same hazard · mis labeling

See all →

Similar recalls