Class II · Moderate risk
Mirtazapine Tablets
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Mirtazapine Tablets
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
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.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-031-05
Affected NDC
13107-0031-05
Compare with the code on your package — it is the most precise check available.
Drug: Mirtazapine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Mirtazapine NDC 13107-0031 |
15 mg/1 | Tablet, Film Coated Oral |
Aurolife Pharma LLC | Rx |
- Recalling firm
- AuroMedics Pharma LLC
- NDC code
- 13107-031-05
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0636-2020 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Mirtazapine recalls
See all
Class I · High risk
Mirtazapine Tablets
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.
Class II · Moderate risk
Mirtazapine Tablets
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled
Class II · Moderate risk
Mirtazapine Tablets
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle
Class II · Moderate risk
All mirtazapine Products
Lack of Processing Controls
Other recalls by AuroMedics Pharma LLC
All 2019 recalls
Class II · Moderate risk
Fondaparinux Sodium Injection
Subpotent Drug: Out of specification for assay
Class III · Low risk
Tranexamic Acid Injection
Presence of Particulate Matter: Piece of metal found in a vial
Class II · Moderate risk
Acyclovir Sodium Injection
Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
Class I · High risk
Polymyxin B for Injection USP
Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
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