FDA Drug recall D-1234-2020
Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc
- FDA Drug
- Class II
- terminated
- Published 2020-04-22
On 2020-04-22 the FDA classified a Class II recall of Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc by Aurobindo Pharma Usa, citing CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1234-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-03-18 |
| Published | 2020-04-22 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Aurobindo Pharma Usa |
| Distribution | US |
Product
Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-053-90
Reason
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Identifiers
| ndc | 65862-050-30 |
|---|---|
| ndc | 65862-050-45 |
| ndc | 65862-050-90 |
| ndc | 65862-050-01 |
| ndc | 65862-050-00 |
| ndc | 65862-050-99 |
| ndc | 65862-050-26 |
| ndc | 65862-051-30 |
| ndc | 65862-051-45 |
| ndc | 65862-051-90 |
| ndc | 65862-051-01 |
| ndc | 65862-051-00 |
| ndc | 65862-051-99 |
| ndc | 65862-051-26 |
| ndc | 65862-052-30 |
| ndc | 65862-052-45 |
| ndc | 65862-052-90 |
| ndc | 65862-052-01 |
| ndc | 65862-052-00 |
| ndc | 65862-052-99 |
| ndc | 65862-052-26 |
| ndc | 65862-053-30 |
| ndc | 65862-053-45 |
| ndc | 65862-053-90 |
| ndc | 65862-053-01 |
| ndc | 65862-053-00 |
| ndc | 65862-053-99 |
| ndc | 65862-053-22 |
| ndc | 65862-054-30 |
| ndc | 65862-054-45 |
| ndc | 65862-054-90 |
| ndc | 65862-054-00 |
| ndc | 65862-054-99 |
| ndc | 65862-054-39 |
| code_info | Lot #: 05319004A1, Exp. Date 03/2022 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1234-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.