# FDA recall D-1274-2019

> **Sagent Pharmaceuticals Inc** · Class II · drug recall initiated 2019-04-30.

## Product

Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL  Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, NDC:  25021-701-02

## Reason for recall

Lack of Sterility Assurance: Microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.

## Distribution

Nationwide USA and Puerto Rico

## Key facts

- **Recall number:** D-1274-2019
- **Recalling firm:** Sagent Pharmaceuticals Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-04-30
- **Report date:** 2019-05-15
- **Termination date:** 2020-09-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Schaumburg, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1274-2019

## Citation

> AI Analytics. FDA recall D-1274-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-1274-2019. Source: US FDA. Licensed CC0.

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