Recalls / Class I
Class ID-0637-2020
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Mirtazapine Tablets, USP, 7.5 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-001-05
- Brand name
- Mirtazapine
- Generic name
- Mirtazapine
- Active ingredient
- Mirtazapine
- Route
- Oral
- NDCs
- 13107-001, 13107-031, 13107-003, 13107-032
- FDA application
- ANDA076921
- Affected lot / code info
- Lot #: 03119002A3, Exp 3/2022
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.
Recalling firm
- Firm
- AuroMedics Pharma LLC
- Manufacturer
- Aurolife Pharma LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, N/A, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2019-11-20
- FDA classified
- 2020-01-02
- Posted by FDA
- 2019-12-18
- Terminated
- 2024-02-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0637-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.