# FDA recall D-0147-2024

> **STAQ Pharma, Inc.** · Class II · drug recall initiated 2023-11-29.

## Product

ROPivacaine HCl 0.2% PF in Sodium Chloride 1,000 mg/500 mL (2 mg per mL) Injection, 500 mL bags, Rx only, STAQ Pharma Inc. 14135 E 42nd Ave, Unit 50, Denver, Colorado 80239, NDC 73177-0109-26,

## Reason for recall

STAQ Pharma Inc. received consumer complaints related to leaking bags and other potential bag concerns. Upon investigation, they determine the source of the issue was with the bag manufacturer who released bags Lot # 134142-001A which had failed internal QC tests for leaks.

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0147-2024
- **Recalling firm:** STAQ Pharma, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Completed
- **Initiation date:** 2023-11-29
- **Report date:** 2023-12-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Denver, CO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0147-2024

## Citation

> AI Analytics. FDA recall D-0147-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0147-2024. Source: US FDA. Licensed CC0.

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