CLASS II Drug recall · Reported 11 Dec 2019 · FDA Enforcement Report
fentaNYL 500 mcg/ (2 mcg/mL) ROPivacaine HCl 2% 500 mg recalled
QuVa Pharma is recalling fentaNYL 500 mcg/ (2 mcg/mL) ROPivacaine HCl 2% 500 mg/ (2 mg/mL) in 9% Sodium Chloride, 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-0552-2020
- 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 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
Where it was distributed
Nationwide.
Questions about this recall
Is fentaNYL 500 mcg/ (2 mcg/mL) ROPivacaine HCl 2% 500 mg/ (2 mg/mL) in 9% Sodium Chloride recalled?
Yes. QuVa Pharma recalled fentaNYL 500 mcg/ (2 mcg/mL) ROPivacaine HCl 2% 500 mg/ (2 mg/mL) in 9% Sodium Chloride on 12 Nov 2019. The recall is Class II and its status is Terminated. Recall number D-0552-2020.
Why was it recalled?
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Which lots are affected?
Lots: 10029346 Exp. 11/15/2019, 10029347 Exp. 11/15/2019, 10029982 Exp. 11/22/2019, 10029347 Exp. 11/15/2019, 10029982 Exp. 11/22/2019, 10030017 Exp. 11/24/2019, 10029982 11/22/2019, 10030017 Exp. 11/24/2019, 10030401 Exp. 11/25/2019, 10030017 Exp. 11/24/2019, 10031092 Exp. 12/6/2019, 10030401 Exp. 11/25/2019, 10031092 12/6/2019, 10031349 Exp. 12/12/2019, 10032011 Exp. 12/27/2019, 10032012 Exp. 12/27/2019, 10032505 Exp. 1/5/2020, 10032447 Exp. 1/2/2020, 10032932 Exp. 1/13/2020,
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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 |