# FDA recall D-0046-2015

> **Micro Labs Usa, Inc                                    S** · Class II · drug recall initiated 2014-10-09.

## Product

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: Micro Labs Limited, Goa-403 722, INDIA, Manufactured for: Micro Labs USA, Inc., Princeton, NJ 08540

## Reason for recall

Failed Stability Specifications: Micro Labs is recalling two lots due to out of specification results during stability testing.

## Distribution

CT, FL, MD, MS, NY

## Key facts

- **Recall number:** D-0046-2015
- **Recalling firm:** Micro Labs Usa, Inc                                    S
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-10-09
- **Report date:** 2014-11-05
- **Termination date:** 2015-12-29

- **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-0046-2015

## Citation

> AI Analytics. FDA recall D-0046-2015. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0046-2015. Source: US FDA. Licensed CC0.

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