CLASS II Drug recall · Reported 11 Dec 2019 · FDA Enforcement Report
fentaNYL 500 mcg/ (2 mcg/mL) BUPivacaine HCl recalled by QuVa Pharma
QuVa Pharma is recalling fentaNYL 500 mcg/ (2 mcg/mL) BUPivacaine HCl 0625% 156.25 mg/ 625 mg/mL) in 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-0549-2020
- 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 0.0625% 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
Where it was distributed
Nationwide.
Questions about this recall
Is fentaNYL 500 mcg/ (2 mcg/mL) BUPivacaine HCl 0625% 156.25 mg/ 625 mg/mL) in 9% Sodium recalled?
Yes. QuVa Pharma recalled fentaNYL 500 mcg/ (2 mcg/mL) BUPivacaine HCl 0625% 156.25 mg/ 625 mg/mL) in 9% Sodium on 12 Nov 2019. The recall is Class II and its status is Terminated. Recall number D-0549-2020.
Why was it recalled?
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Which lots are affected?
Lots: 10029288 Exp. 11/14/2019, 10029762 Exp. 11/14/2019, 10029788 Exp. 11/18/2019, 10029838 Exp. 11/19/2019, 10029948 Exp. 11/21/2019, 10029949 Exp. 11/21/2019, 10030337 Exp. 11/24/2019, 10029838 Exp. 11/19/2019, 10030539 Exp. 11/28/2019, 10030943 Exp. 12/3/2019, 10030964 Exp. 12/3/2019, 10030963 Exp. 12/3/2019, 10030964 Exp. 12/3/2019, 10030888 Exp. 12/2/2019, 10030963 Exp. 12/3/2019, 10031129 Exp. 12/8/2019, 10031284 Exp. 12/11/2019, 10031414 Exp. 12/15/2019, 10031435 Exp. 12/16/2019, 10031735 Exp. 12/22/2019, 10032253 Exp. 12/30/2019, 10030455 Exp. 11/26/2019, 10032535 Exp. 1/6/2020, 10032280 Exp. 12/31/2019, 10030455 Exp. 11/26/2019, 10032535 Exp. 1/6/2020, 10033009 Exp. 1/15/2020, 10032585 Exp. 1/14/2020, 10033009 Exp. 1/15/2020
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 |