Reported Dec 11, 2019 · Terminated
fentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.2% 400 mg/200 mL (2 mg/mL) in 0.9% Sodium Chloride 200 mL CADD…
QuVa 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: QuVa Pharma, Inc. · 1075 W Park One Dr Ste 100 · Sugar Land, TX · 77478-2576
Is this the product you have?
- fentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.2% 400 mg/200 mL (2 mg/mL) in 0.9% Sodium Chloride 200 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1440-76
- Lot codes and dates
- Lots
10029307 Exp. 11/14/201910029939 Exp. 11/20/201910029884 Exp. 11/19/201910029915 Exp. 11/20/201910030385 Exp. 11/25/201910030386 Exp. 11/25/201910030923 Exp. 12/11/201910031320 Exp. 12/11/201910031025 Exp. 12/12/201910031024 Exp. 12/12/201910032678 Exp. 1/8/202010032993 Exp. 1/14/2020
- Lots
This recall covers 27 products
The agency filed one notice per product. You are reading one of them; the other 26 are below.
14 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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