# FDA recall D-0246-2015

> **Micro Labs Usa, Inc                                    S** · Class III · drug recall initiated 2014-08-19.

## 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 for recall

Failed Impurities/Degradation Specifications: Product failed Impurity content (Butylated Hydroxy Anisole Content) against shelf life specification.

## Distribution

NY

## Key facts

- **Recall number:** D-0246-2015
- **Recalling firm:** Micro Labs Usa, Inc                                    S
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-08-19
- **Report date:** 2014-11-19
- **Termination date:** 2016-04-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0246-2015

## Citation

> AI Analytics. FDA recall D-0246-2015. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0246-2015. Source: US FDA. Licensed CC0.

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