CLASS II Drug recall · Reported 11 Dec 2019 · FDA Enforcement Report
fentaNYL 500 mcg/ (2 mcg/mL) Bupivacaine HCl 1% 250 mg recalled
QuVa Pharma is recalling fentaNYL 500 mcg/ (2 mcg/mL) Bupivacaine HCl 1% 250 mg/ (1 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-0546-2020
- 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) Bupivacaine HCl 0.1% 250 mg/250 mL (1 mg/mL) in 0.9% Sodium Chloride 250 mL Bag, Rx only, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1160-37
Where it was distributed
Nationwide.
Questions about this recall
Is fentaNYL 500 mcg/ (2 mcg/mL) Bupivacaine HCl 1% 250 mg/ (1 mg/mL) in 9% Sodium Chloride recalled?
Yes. QuVa Pharma recalled fentaNYL 500 mcg/ (2 mcg/mL) Bupivacaine HCl 1% 250 mg/ (1 mg/mL) in 9% Sodium Chloride on 12 Nov 2019. The recall is Class II and its status is Terminated. Recall number D-0546-2020.
Why was it recalled?
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Which lots are affected?
Lots: 10029297 Exp. 11/14/2019 10029199 Exp. 11/17/2019, 10029737 Exp. 11/17/2019, 10029763 Exp. 11/17/2019, 10029785 Exp. 11/18/2019, 10029789 Exp. 11/18/2019, , 10029790 Exp. 11/18/2019, 10029894 Exp. 11/20/2019, 10029950 Exp. 11/21/2019, 10030006 Exp. 11/24/2019, , 10030007 Exp. 11/27/2019, 10030336 Exp. 11/27/2019, , 10030941 Exp. 12/3/2019, 10030886 Exp. 12/2/2019, 10030453 Exp. 11/26/2019, 10030887 Exp. 12/4/2019, 10030990 Exp. 12/4/2019, 10030991 Exp. 12/4/2019,, 10030942 Exp. 12/3/2019, 10030886 Exp. 12/2/2019, 10030909 Exp. 12/2/2019, 10030431 Exp. 11/26/2019, 10030432 Exp. 11/26/2019, 10030454 Exp. 11/26/2019, 10031056 Exp. 12/5/2019, 10031057 Exp. 12/5/2019, 10030990 Exp. 12/4/2019, 10030886 Exp. 12/2/2019,, 10030454 Exp. 11/26/2019, 10031056 Exp. 12/5/2019, 10031058 Exp. 12/5/2019, 10031087 Exp. 12/6/2019, 10031153 Exp. 12/8/2019, 10031087 Exp. 12/6/2019, 10031088 Exp. 12/6/2019, 10031376 Exp. 12/6/2019, 10031178 Exp. 12/9/2019, 10031179 Exp. 12/9/2019, 10031152 Exp. 12/8/2019, 10031153 Exp. 12/8/2019, 10031376 Exp. 12/6/2019, 10031236 Exp. 12/10/2019, 10031179 Exp. 12/9/2019, 10031152 Exp. 12/8/2019, 10031236 Exp. 12/10/2019, 10031237 Exp. 12/10/2019, 10031732 Exp. 12/22/2019, 10031616 Exp. 12/19/2019, 10031617 Exp. 12/22/2019, 10031731 Exp. 12/22/2019, 10031732 Exp. 12/22/2019, 10031616 Exp. 12/19/2019, 10031617 Exp. 12/22/2019, 10031950 Exp. 12/26/2019, 10031979 Exp. 12/29/2019, 10031980 Exp. 12/30/2019, 10032308 Exp. 12/31/2019, 10032309 Exp. 12/31/2019, 10032415 Exp. 1/2/2020, 10032416 Exp. 1/2/2020, 10032804 Exp. 1/5/2020, 10032805 Exp. 1/5/2020, 10032582 Exp. 1/6/2020, 10032808 Exp. 1/6/2020, 10032809 Exp. 1/6/2020, 10032810 Exp. 1/6/2020, 10032559 Exp. 1/6/2020, 10032582 Exp. 1/6/2020, 10032809 Exp. 1/6/2020, 10032810 Exp. 1/6/2020, 10032811 Exp. 1/6/2020, 10032805 Exp. 1/5/2020, 10032805 Exp. 1/5/2020, 10032534 Exp. 1/14/2020, 10032534 Exp. 1/14/2020, 10032534 Exp. 1/14/2020, 10032534 Exp. 1/14/2020, 10032534 Exp. 1/14/2020, 10032534 Exp. 1/14/2020, 10031951 Exp. 12/26/2019, 10031951 Exp. 12/26/2019, 10031951 Exp. 12/26/2019, 10031951 Exp. 12/26/2019, 10033008 Exp. 1/15/2020, 10033008 Exp. 1/15/2020, 10032038 Exp. 1/19/2020, 10032038 Exp. 1/19/2020, 10032039 Exp. 1/19/2020, 10033008 Exp. 1/15/2020, 10032039 Exp. 1/19/2020
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 |