Reported Dec 11, 2019 · Terminated
fentaNYL 500 mcg/250 mL (2 mcg/mL) BUPivacaine HCl 0.0625% 156.25 mg/250 mL (0.625 mg/mL) in 0.9% Sodium Chloride in…
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) BUPivacaine HCl 0.0625% 156.25 mg/250 mL (0.625 mg/mL) in 0.9% Sodium Chloride in 250 mL Bag, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1269-37
- Lot codes and dates
- Lots
10029288 Exp. 11/14/201910029762 Exp. 11/14/201910029788 Exp. 11/18/201910029838 Exp. 11/19/201910029948 Exp. 11/21/201910029949 Exp. 11/21/201910030337 Exp. 11/24/201910029838 Exp. 11/19/201910030539 Exp. 11/28/201910030943 Exp. 12/3/201910030964 Exp. 12/3/201910030963 Exp. 12/3/201910030964 Exp. 12/3/201910030888 Exp. 12/2/201910030963 Exp. 12/3/201910031129 Exp. 12/8/201910031284 Exp. 12/11/201910031414 Exp. 12/15/201910031435 Exp. 12/16/201910031735 Exp. 12/22/201910032253 Exp. 12/30/201910030455 Exp. 11/26/201910032535 Exp. 1/6/202010032280 Exp. 12/31/201910030455 Exp. 11/26/201910032535 Exp. 1/6/202010033009 Exp. 1/15/202010032585 Exp. 1/14/202010033009 Exp. 1/15/2020
- 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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