FDA Drug recall D-0407-2015
Simvastatin Tablets, USP, 20mg a) 90- count bottle (42517-0020-10), b) 1000-count-bottle (NDC 42571-0020-10), Rx only, Manufactured by: Mic…
- FDA Drug
- Class III
- terminated
- Published 2015-03-18
On 2015-03-18 the FDA classified a Class III recall of Simvastatin Tablets, USP, 20mg a) 90- count bottle (42517-0020-10), b) 1000-count-bottle (NDC 42571-0020-10), Rx only, Manufactured by: Mic… 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-0407-2015 |
| 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, 20mg a) 90- count bottle (42517-0020-10), b) 1000-count-bottle (NDC 42571-0020-10), Rx only, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc.,Princeton, NJ 08540
Reason
Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
Identifiers
| code_info | Lot #: STCG005, Exp 01/2015; Lot #: STCG011, Exp 03/2015; Lot #: STCG012, Exp 02/2015. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Other recalls by Micro Labs Usa S
- 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 · 2015-03-18 · Micro Labs Usa S - Simvastatin Tablets, USP, 40mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro…
FDA Drug · Class III · 2015-03-18 · Micro Labs Usa S - LOSARTAN POTASSIUM TABLETS USP, 25 mg, 1000 Tablet Bottles, Rx Only
FDA Drug · Class II · 2014-11-26 · Micro Labs Usa S - Simvastatin Tablets, USP, 10 mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited, Goa-403 722, INDIA, Manufactured for: Micr…
FDA Drug · Class III · 2014-11-19 · Micro Labs Usa S - GLIMEPIRIDE TABLETS, USP 2 mg, a)100 count bottle, (NDC 42571-101-01), b) 500 count Bottle (NDC 42571-101-05), Rx only, Manufactured by: Mi…
FDA Drug · Class II · 2014-11-05 · Micro Labs Usa S
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0407-2015%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.