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Drug FDA Class II Ongoing Contamination / non-sterility

fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77

QuVa Pharma, Inc. Published Apr 2, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact QuVa Pharma, Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Lack of Assurance of Sterility

Hazards

Lack of Assurance of Sterility · primary

Affected products (1)

fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77478. NDC: 70092-1255-75

2,310 cassettes

Lot codes: 10140284, 10140510, 10140916
Code info: Lot, expiry: Lots 10140284, 10140285, 10140315, 10140316, exp 04/08/2025; Lot 10140510, exp 04/14/2025; Lot 10140916, exp 04/24/2025

Affected areas

Nationwide

Timeline

  1. Initiated
    Mar 6, 2025
  2. Published
    Apr 2, 2025
Recall number
D-0296-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.