Drug recall D-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
Reason for recall
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Lots and codes
Lot #: 05319004A1, Exp. Date 03/2022
Recall details
- Recalling firm
- Aurobindo Pharma USA Inc., East Windsor, NJ
- Quantity
- 26976 units
- Distribution
- Nationwide within the United States
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 18, 2020
- Terminated
- March 25, 2024
Related products
- Simvastatin – drug information
- NDC 65862-050 Simvastatin · Simvastatin 5 mg/1 · Aurobindo Pharma Limited
- NDC 65862-053 Simvastatin · Simvastatin 40 mg/1 · Aurobindo Pharma Limited
- NDC 65862-051 Simvastatin · Simvastatin 10 mg/1 · Aurobindo Pharma Limited
- NDC 65862-054 Simvastatin · Simvastatin 80 mg/1 · Aurobindo Pharma Limited
- NDC 65862-052 Simvastatin · Simvastatin 20 mg/1 · Aurobindo Pharma Limited