# FDA recall D-0409-2015

> **Micro Labs Usa, Inc                                    S** · Class III · drug recall initiated 2014-12-04.

## 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 for recall

Failed Impurities/Degradation Specifications: Product failed a known impurity specification.

## Distribution

Nationwide.

## Key facts

- **Recall number:** D-0409-2015
- **Recalling firm:** Micro Labs Usa, Inc                                    S
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-12-04
- **Report date:** 2015-03-18
- **Termination date:** 2018-04-25

- **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-0409-2015

## Citation

> AI Analytics. FDA recall D-0409-2015. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0409-2015. Source: US FDA. Licensed CC0.

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