# FDA recall D-1248-2019

> **Aurobindo Pharma USA Inc.** · Class I · drug recall initiated 2019-03-28.

## Product

Lidocaine HCl Injection, USP 1 % 50 mg/5 mL (10 mg/mL), 5mL vial,  Rx only, Mrd. in India for: AuroMedics Pharna LLC. E Windsor, NJ 08520   NDC 55150-162-05

## Reason for recall

Presence of Particulate Matter: One vial was found to contain a hair.

## Distribution

Product is being held at a distributor site in Mexico, Asheboro, NC, Charlotte, NC and Santa Teresa, NM and not further distributed in the U.S. Market.

## Key facts

- **Recall number:** D-1248-2019
- **Recalling firm:** Aurobindo Pharma USA Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-03-28
- **Report date:** 2019-04-17
- **Termination date:** 2024-04-11

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1248-2019

## Citation

> AI Analytics. FDA recall D-1248-2019. Retrieved 2026-07-05 from https://api.ai-analytics.org/recall/D-1248-2019. Source: US FDA. Licensed CC0.

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