# FDA recall D-0357-2019

> **Lupin Pharmaceuticals Inc.** · Class I · drug recall initiated 2018-12-20.

## Product

Ceftriaxone for Injection USP, 1 g, packaged in a) one Single Use Vial (NDC 68180-633-01) and b) 10 Single Use Vials per box (NDC 68180-633-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland  21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.

## Reason for recall

Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.

## Distribution

Nationwide in the USA and Puerto Rico.

## Key facts

- **Recall number:** D-0357-2019
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-12-20
- **Report date:** 2019-01-16
- **Termination date:** 2020-08-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Baltimore, MD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0357-2019

## Citation

> AI Analytics. FDA recall D-0357-2019. Retrieved 2026-05-31 from https://api.ai-analytics.org/recall/D-0357-2019. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*