FDA Drug recall D-0246-2015
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
- terminated
- Published 2014-11-19
On 2014-11-19 the FDA classified a Class III recall of Simvastatin Tablets, USP, 10 mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited, Goa-403 722, INDIA, Manufactured for: Micr… by Micro Labs Usa S, citing failed Impurities/Degradation Specifications: Product failed Impurity content (Butylated Hydroxy Anisole Content) against shelf life specification.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0246-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-08-19 |
| Published | 2014-11-19 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Micro Labs Usa S |
| Distribution | NY |
Product
Simvastatin Tablets, USP, 10 mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited, Goa-403 722, INDIA, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540, NDC 42571-010-90
Reason
Failed Impurities/Degradation Specifications: Product failed Impurity content (Butylated Hydroxy Anisole Content) against shelf life specification.
Identifiers
| code_info | Lot #: STBG005, Exp 2/2015 |
|---|
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 - 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 · 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 - 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-0246-2015%22
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