# FDA recall D-1815-2019

> **Infusion Options, Inc.** · Class II · drug recall initiated 2019-06-12.

## Product

TRASTUZUMAB 427 MG / 250 ml NS IVPB; TRASTUZUMAB 531 MG / 250 ML NS IVPB; TRASTUZUMAB 276 MG / 250 ML NS IVPB; TRASTUZUMAB 360 MG / 250 ML NS IVPB; TRASTUZUMAB 757 MG / 250 ML NS IVPB  TRASTUZUMAB 450 MG / 250 ML NS IVPB; TRASTUZUMAB 120 MG / 250 ML NS IVPB; TRASTUZUMAB 164 MG / 250 ML NS IVPB; TRASTUZUMAB 444 MG / 250 ml NS IVPB; TRASTUZUMAB 634 MG / 250 ML NS IVPB; TRASTUZUMAB 330 MG / 250 ML NS IVPB; TRASTUZUMAB 781 MG / 250 ML NS IVPB; TRASTUZUMAB 376 mg / 250 ML NS IVPB; TRASTUZUMAB 114 MG / 250 ML NS IVPB; TRASTUZUMAB 266 MG / 250 ML NS IVPB   TRASTUZUMAB 323 MG / 250 ML NS IVPB; Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233

## Reason for recall

Lack of Assurance of Sterility

## Distribution

NY only

## Key facts

- **Recall number:** D-1815-2019
- **Recalling firm:** Infusion Options, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-06-12
- **Report date:** 2019-08-21
- **Termination date:** 2025-03-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Brooklyn, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1815-2019

## Citation

> AI Analytics. FDA recall D-1815-2019. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-1815-2019. Source: US FDA. Licensed CC0.

---

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