Reported Dec 11, 2019 · Terminated
fentaNYL 500 mcg/250 mL (2 mcg/mL) ROPivacaine HCl 0.2% 500 mg/250 mL (2 mg/mL) in 0.9% Sodium Chloride 250 mL Bag Rx,…
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 500 mcg/250 mL (2 mcg/mL) ROPivacaine HCl 0.2% 500 mg/250 mL (2 mg/mL) in 0.9% Sodium Chloride 250 mL Bag Rx, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1225-37
- Lot codes and dates
- Lots
10029346 Exp. 11/15/201910029347 Exp. 11/15/201910029982 Exp. 11/22/201910029347 Exp. 11/15/201910029982 Exp. 11/22/201910030017 Exp. 11/24/201910029982 11/22/201910030017 Exp. 11/24/201910030401 Exp. 11/25/201910030017 Exp. 11/24/201910031092 Exp. 12/6/201910030401 Exp. 11/25/201910031092 12/6/201910031349 Exp. 12/12/201910032011 Exp. 12/27/201910032012 Exp. 12/27/201910032505 Exp. 1/5/202010032447 Exp. 1/2/202010032932 Exp. 1/13/2020
- 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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