FDA Drug recall D-0409-2015
Simvastatin Tablets, USP, 80mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro…
- FDA Drug
- Class III
- terminated
- Published 2015-03-18
On 2015-03-18 the FDA classified a Class III recall of Simvastatin Tablets, USP, 80mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro… by Micro Labs Usa S, citing failed Impurities/Degradation Specifications: Product failed a known impurity specification.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0409-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-12-04 |
| Published | 2015-03-18 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Micro Labs Usa S |
| Distribution | US |
Product
Simvastatin Tablets, USP, 80mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540 NDC 42571-080-90.
Reason
Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
Identifiers
| code_info | Lot #: STEG004, Exp 2/2015; Lot #: STEG006 Exp 3/2015 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0409-2015%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.