Class II · Moderate risk
Mirtazapine Tablets
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
National Drug Code
Is NDC 13107-0031-05 recalled?
Mirtazapine · 500 TABLET, FILM COATED in 1 BOTTLE (13107-031-05)
Yes — this exact package was recalled
1 FDA recall names the code 13107-0031-05 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
- Active ingredient
- Mirtazapine
- Strength
- MIRTAZAPINE 15 mg/1
- Form
- Tablet, Film Coated · Oral
- Labeler
- Aurolife Pharma LLC
- Type
- Human Prescription Drug
- Product code
- 13107-0031
Recalls naming this package
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.
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Other recalled products from this labeler
- 13107-0014 Glycopyrrolate 3
- 13107-0059 Acetaminophen and Codeine Phosphate 2
- 13107-0001 Mirtazapine 1
- 13107-0046 Oxycodone and Acetaminophen 1
- 13107-0058 Acetaminophen and Codeine Phosphate 1
- 13107-0060 Acetaminophen and Codeine Phosphate 1
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