# FDA recall D-1335-2020

> **QuVa Pharma, Inc.** · Class III · drug recall initiated 2020-04-23.

## Product

R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride solution 50 mL in 60 mL Syringe, Compounded by QuVa 519 Bloombury, NJ 08804,  NDC 70092143350

## Reason for recall

Presence of Particulate Matter: Fresenius Kabi recalling vials of Ketorolac

## Distribution

Distributed Nationwide in the US.

## Key facts

- **Recall number:** D-1335-2020
- **Recalling firm:** QuVa Pharma, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-04-23
- **Report date:** 2020-07-01
- **Termination date:** 2021-01-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sugar Land, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1335-2020

## Citation

> AI Analytics. FDA recall D-1335-2020. Retrieved 2026-05-29 from https://api.ai-analytics.org/recall/D-1335-2020. Source: US FDA. Licensed CC0.

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