CLASS II Drug recall · Reported 11 Dec 2019 · FDA Enforcement Report
fentaNYL 1000 mcg/ (10 mcg/mL) recalled by QuVa Pharma
QuVa Pharma is recalling fentaNYL 1000 mcg/ (10 mcg/mL) in 9% Sodium Chloride CADD Preservative Free, Rx, QuVA, 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-0571-2020
- 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 1000 mcg/100 mL (10 mcg/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 70092-1250-75
Where it was distributed
Nationwide.
Questions about this recall
Is fentaNYL 1000 mcg/ (10 mcg/mL) in 9% Sodium Chloride CADD Preservative Free, Rx, QuVA recalled?
Yes. QuVa Pharma recalled fentaNYL 1000 mcg/ (10 mcg/mL) in 9% Sodium Chloride CADD Preservative Free, Rx, QuVA on 12 Nov 2019. The recall is Class II and its status is Terminated. Recall number D-0571-2020.
Why was it recalled?
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Which lots are affected?
Lots: 10030341 11/24/2019, 10031102 12/6/2019, 10031555 Exp. 12/18/2019, 10031554 Exp. 12/18/2019, 10031803 Exp. 12/23/2019, 10031776 Exp. 12/22/2019, 10032266 Exp. 12/30/2019, 10032267 Exp. 12/30/2019, 10032321 Exp. 12/31/2019, 10032320 Exp. 12/31/2019, 10032544 Exp. 1/5/2020, 10032515 Exp. 1/5/2020
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 |