# FDA recall D-0141-2017

> **Sandoz Inc** · Class II · drug recall initiated 2016-11-09.

## Product

L-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk Package Vials (NDC 66758-005-01), packaged in 5 x 50 mL Vials per carton(NDC 66758-005-02), Rx only, Manufactured for: Sandoz, Inc., Princeton, NJ.

## Reason for recall

Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.

## Distribution

Nationwide throughout the USA

## Key facts

- **Recall number:** D-0141-2017
- **Recalling firm:** Sandoz Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-11-09
- **Report date:** 2016-11-23
- **Termination date:** 2017-10-17

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0141-2017

## Citation

> AI Analytics. FDA recall D-0141-2017. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-0141-2017. Source: US FDA. Licensed CC0.

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