CLASS II Drug recall · Reported 11 Dec 2019 · FDA Enforcement Report
fentaNYL 200 mcg/ (2 mcg/mL) BUPivacaine HCl 0.125% 125 mg recalled
QuVa Pharma is recalling fentaNYL 200 mcg/ (2 mcg/mL) BUPivacaine HCl 0.125% 125 mg/ (1.25 mg/mL) in 0.9% Sodium, distributed nationwide in the US. The recall was initiated on 12 Nov 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0550-2020
- FDA event ID
- 84263
- Recalling firm
- QuVa Pharma, Sugar Land, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Nov 2019
- FDA classified
- 3 Dec 2019
- Reported
- 11 Dec 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Pain Medication
Timeline
| 12 Nov 2019 | Recall initiated by company | |
| 3 Dec 2019 | Classified by FDA | +21 days |
| 11 Dec 2019 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Product as listed by the FDA
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
Where it was distributed
Nationwide.
Questions about this recall
Why was it recalled?
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Which lots are affected?
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. 1/6/2020, 10032557 Exp. 1/6/2020, 10032849 Exp. 1/12/2020, 10032532 Exp. 1/14/2020, 10033351 Exp. 1/16/2020, 10031040 Exp. 12/5/2019
Where was it sold?
Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
26 other products · FDA event 84263This product is part of a recall event; the main page for the event is fentaNYL 2000 mcg/ (20 mcg/mL) in 0.9% Sodium Chloride recalled.
More recalls from QuVa Pharma
All 38| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Methohexital Sodium, 100 mg/ (10 mg/mL), Total Volume recalled | QuVa Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl recalled | QuVa Pharma | Particulate Matter | Nationwide |
| Drug | CLASS II | fentaNYL Citrate PF 200 mcg recalled by QuVa Pharma | QuVa Pharma | Sterility | Nationwide |
| Drug | CLASS II | fentaNYL Citrate PF 200 mcg recalled by QuVa Pharma | QuVa Pharma | Sterility | Nationwide |
| Drug | CLASS II | fentaNYL Citrate PF 200 mcg recalled by QuVa Pharma | QuVa Pharma | Sterility | Nationwide |
Other Fentanyl recalls
All 248| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | fentaNYL Citrate, 1,000 mcg recalled by OurPharma | OurPharma | Other | Nationwide |
| Drug | CLASS II | fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg recalled | IntegraDose Compounding Services | Potency & Assay | Nationwide |
| Drug | CLASS II | fentaNYL Citrate Injectable Solution recalled by Wells Pharma of Houston | Wells Pharma of Houston | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | fentaNYL Citrate Injectable Solution, Narcotic, CII recalled | Wells Pharma of Houston | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | fentaNYL Citrate Injectable Solution, Narcotic, Cii recalled | Wells Pharma of Houston | Manufacturing (CGMP) Deviations | Nationwide |