fentaNYL 200 mcg/100 mL
Medicine recall D-0550-2020. Published in FDA’s Enforcement Report on Dec 11, 2019.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Dec 11, 2019. Copied from openFDA on Oct 20, 2026.
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.125% 125 mg/100 mL (1.25 mg/mL) in 0.9% Sodium Chloride Preservative Free, 100 mL in 150 Bag, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1104-36
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lots: 1002929 Exp. 11/14/2019, 10029839 Exp. 11/19/2019, 10029840 Exp. 11/19/2019, 10029806 Exp. 11/18/2019, 10029860 Exp. 11/18/2019, 10030370 Exp. 11/25/2019, 10030002 Exp. 11/24/2019, 10030001 Exp. 11/25/2019, 10030003 Exp. 11/24/2019,…
Every code shown here, 1,993 characters
Lots: 1002929 Exp. 11/14/2019, 10029839 Exp. 11/19/2019, 10029840 Exp. 11/19/2019, 10029806 Exp. 11/18/2019, 10029860 Exp. 11/18/2019, 10030370 Exp. 11/25/2019, 10030002 Exp. 11/24/2019, 10030001 Exp. 11/25/2019, 10030003 Exp. 11/24/2019, 10030013 Exp. 11/24/2019, 10030014 Exp. 11/24/2019, 10030001 Exp. 11/25/2019, 10030013 Exp. 11/24/2019, 10030001 Exp. 11/25/2019, 10030538 Exp. 11/28/2019, 10030906 Exp. 11/28/2019, 10030905 Exp. 11/28/2019, 10030429 Exp. 11/26/2019, 10031151 Exp. 12/8/2019, 10031039 Exp. 12/5/2019, 10031282 Exp. 12/11/2019, 10031412 Exp. 12/15/2019, 10031432 Exp. 12/16/2019, 10031460 Exp. 12/16/2019, 10031461 Exp. 12/16/2019, 10031462 Exp. 12/16/2019, 10031567 Exp. 12/18/2019, 10031613 Exp. 12/19/2019, 10031614 Exp. 12/19/2019, 10031567 Exp. 12/18/2019, 10031695 Exp. 12/22/2019, 10031667 Exp. 12/20/2019, 10031788 Exp. 12/23/2019, 10031789 Exp. 12/23/2019, 10031790 Exp. 12/23/2019, 10031812 Exp. 12/23/2019, 10031475 Exp. 12/20/2019, 10031476 Exp. 12/20/2019, 10031641 Exp. 12/20/2019, 10031667 Exp. 12/20/2019, 10031668 Exp. 12/20/2019, 10031566 Exp. 12/18/2019, 10031200 Exp. 12/10/2019, 10032006 Exp. 12/27/2019, 10032007 Exp. 12/27/2019, 10032037 Exp. 12/27/2019, 10032249 Exp. 12/30/2019, 10032276 Exp. 12/30/2019, 10031916 Exp. 12/25/2019, 10031917 Exp. 12/25/2019, 10031843 Exp. 12/24/2019, 10031844 Exp. 12/24/2019, 10031866 Exp. 12/24/2019, 10031867 Exp. 12/24/2019, 10032248 Exp. 12/30/2019, 10032276 Exp. 12/30/2019, 10031811 Exp. 12/25/2019, 10031916 Exp. 12/25/2019, 10031868 Exp. 12/24/2019, 10032306 Exp. 12/31/2019, 10032307 Exp. 12/31/2019, 10032332 Exp. 12/31/2019, 10032364 Exp. 1/1/2020, 10032365 Exp. 1/1/2020, 10032389 Exp. 1/1/2020, 10032390 Exp. 1/2/2020, 10032331 Exp. 12/31/2019 10032556 Exp. 1/6/2020, 10031974 Exp. 12/29/2019, 10032556 Exp.1/6/2020 10032557 Exp. 1/6/2020 10032277 Exp. 12/30/2019, 10031974 Exp. 12/29/2019, 10032612 Exp. 1/7/2020, 10032613 Exp. 1/7/2020, 10032635 Exp. 1/7/2020, 10032636 Exp. 1/7/2020, 10032556 Exp.…
FDA’s list runs to 2,125 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Barcodes and drug codes
-
NDC
70092-1104-36
As FDA’s description and codes give them; the UPCs written as digits only.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Nationwide.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Nov 12, 2019.
- FDA classified it on Dec 3, 2019.
- FDA’s Enforcement Report published it on Dec 11, 2019.
- FDA terminated it on Jun 5, 2020.
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- QuVa Pharma, Inc., of Sugar Land, TX.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 2,125 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Drug recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.