Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-053-90
Reported: April 22, 2020 Initiated: March 18, 2020 #D-1234-2020
Product Description
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
Details
- Recalling Firm
- Aurobindo Pharma USA Inc.
- Units Affected
- 26976 units
- Distribution
- Nationwide within the United States
- Location
- East Windsor, NJ
Frequently Asked Questions
What product was recalled? ▼
Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-053-90. Recalled by Aurobindo Pharma USA Inc.. Units affected: 26976 units.
Why was this product recalled? ▼
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 22, 2020. Severity: Moderate. Recall number: D-1234-2020.
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