STAQ Pharma, Inc.: Drug Recall

Recall #D-0147-2024 · 11/29/2023

Class II: Risk

Recall Details

Recall Number
D-0147-2024
Classification
Class II
Product Type
Drug
Recalling Firm
STAQ Pharma, Inc.
Status
Completed
Date Initiated
11/29/2023
Location
Denver, CO, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2616 bags

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.

Product Description

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,

Distribution Pattern

Nationwide within the United States

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.