CLASS II Drug recall · Reported 11 Dec 2019 · FDA Enforcement Report
fentaNYL 200 mcg/ (2 mcg/mL) 0.125% Bupivacaine HCl 125 mg recalled
QuVa Pharma is recalling fentaNYL 200 mcg/ (2 mcg/mL) 0.125% Bupivacaine HCl 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-0557-2020
- 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) 0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL) in 0.9% Sodium Chloride, 100 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1202-75
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: 10029306 Exp. 11/14/2019, 10029881 Exp. 11/18/2019, 10029748 Exp. 11/17/2019, 10029881 Exp. 11/18/2019, 10029882 Exp. 11/18/2019, 10029854 Exp. 11/19/2019, 10029882 Exp. 11/18/2019, 10030947 Exp. 12/3/2019, 10030894 Exp. 12/2/2019, 10030442 Exp. 11/26/2019, 10031295 Exp. 12/11/2019, 10031319 Exp. 12/11/2019, 10031518 Exp. 12/17/2019, 10031553 Exp. 12/17/2019, 10031468 Exp. 12/16/2019, 10032703 Exp. 1/8/2020, 10032594 Exp. 1/6/2020, 10032543 Exp. 1/5/2020, 10031906 Exp. 12/25/2019, 10031882 Exp. 12/24/2019, 10031802 Exp. 12/23/2019, 10032594 Exp. 1/6/2020, 10032543 Exp. 1/5/2020, 10031906 Exp. 12/25/2019, 10031802 Exp. 12/23/2019, 10031775 Exp. 12/22/2019, 10031582 Exp. 12/18/2019, 10032673 Exp. 1/8/2020, 10032021 Exp. 12/27/2019, 10031582 Exp. 12/18/2019, 10032021 Exp. 12/27/2019, 10031960 Exp. 12/26/2019, 10031906 Exp. 12/25/2019, 10031582 Exp. 12/18/2019, 10032405 Exp. 1/1/2020, 10032021 Exp. 12/27/2019, 10031960 Exp. 12/26/2019, 10032380 Exp. 1/1/2020, 10032673 Exp. 1/8/2020
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 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 |