Mirtazapine Tablets, USP, 7.5 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-001-05
Reported: December 18, 2019 Initiated: November 20, 2019 #D-0637-2020
Product Description
Mirtazapine Tablets, USP, 7.5 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-001-05
Reason for Recall
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.
Details
- Recalling Firm
- AuroMedics Pharma LLC
- Units Affected
- N/A
- Distribution
- Nationwide
- Location
- East Windsor, NJ
Frequently Asked Questions
What product was recalled? ▼
Mirtazapine Tablets, USP, 7.5 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-001-05. Recalled by AuroMedics Pharma LLC. Units affected: N/A.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 18, 2019. Severity: Critical. Recall number: D-0637-2020.
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