# FDA recall D-0339-2018

> **Aurobindo Pharma Ltd.** · Class I · drug recall initiated 2018-01-02.

## Product

Ampicillin and Sulbactam for Injection 1.5 g vial, sterile  Dry Powder for injection, 10 vials per carton, Distributed by AuroMedics Pharma LLC. 279 Princeton-Highstown Rd. E. Windsor, NJ 08520, NDC 55150-116-20

## Reason for recall

Presence of Particulate Matter: A confirmed customer report was received for the presence of visible particulate matter, confirmed as glass, within a single vial.

## Distribution

distributed nationwide in the USA

## Key facts

- **Recall number:** D-0339-2018
- **Recalling firm:** Aurobindo Pharma Ltd.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-01-02
- **Report date:** 2018-02-14
- **Termination date:** 2019-09-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hyderabad, N/A, India

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0339-2018

## Citation

> AI Analytics. FDA recall D-0339-2018. Retrieved 2026-06-15 from https://api.ai-analytics.org/recall/D-0339-2018. Source: US FDA. Licensed CC0.

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