Recalls / Class II
Class IID-1234-2020
Product
Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-053-90
- Brand name
- Simvastatin
- Generic name
- Simvastatin
- Active ingredient
- Simvastatin
- Route
- Oral
- NDCs
- 65862-050, 65862-051, 65862-052, 65862-053, 65862-054
- FDA application
- ANDA077691
- Affected lot / code info
- Lot #: 05319004A1, Exp. Date 03/2022
Why it was recalled
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Recalling firm
- Firm
- Aurobindo Pharma USA Inc.
- Manufacturer
- Aurobindo Pharma Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 26976 units
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2020-03-18
- FDA classified
- 2020-04-13
- Posted by FDA
- 2020-04-22
- Terminated
- 2024-03-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1234-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.