# FDA recall D-1175-2017

> **Genentech, Inc.** · Class I · drug recall initiated 2017-09-05.

## Product

Activase (alteplase), 100 mg (58 million IU), Lyophilized vial, packaged with 1 single-dose 100ml vial of sterile water for Injection USP and one transfer device.  Manufactured by: Genentech, Inc. 1 DNA Way, South San Francisco, CA 84080-4990. NDC: 50242-0085-27

## Reason for recall

Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-1175-2017
- **Recalling firm:** Genentech, Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-09-05
- **Report date:** 2017-09-27
- **Termination date:** 2019-01-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** South San Francisco, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1175-2017

## Citation

> AI Analytics. FDA recall D-1175-2017. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1175-2017. Source: US FDA. Licensed CC0.

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