Reported Dec 13, 2023 · Completed
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…
STAQ Pharma, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: STAQ Pharma, Inc. · 14135 E 42nd Ave Ste 50 · Denver, CO · 80239-5214
Is this the product you have?
ROPivacaine HCl 0.2% PF in Sodium Chloride 1000 mg/500 mL (2 mg per mL) Injection500 mL bagsRx onlySTAQ Pharma Inc. 14135 E 42nd AveUnit 50DenverColorado 80239NDC 73177-0109-26
- Lot codes and dates
Lot#: 23109472AExp. date 03/10/202423109473AExp. date 03/11/202423109474AExp. date 03/13/202423109491AExp. date 03/16/202423109492AExp. date 03/19/202423109501AExp. date 03/25/202423109520AExp. date 04/10/202423109521AExp. date 04/13/202423109522AExp. date 04/03/2024
- Amount recalled
- 2616 bags
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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