CLASS III Drug recall · Reported 19 Dec 2018 · FDA Enforcement Report
Norepinephrine 8 mg (32 mcg/mL) added to 0.9% Sodium recalled
QuVa Pharma is recalling Norepinephrine 8 mg (32 mcg/mL) added to 0.9% Sodium Chloride Injection, distributed in California. The recall was initiated on 21 Nov 2018 and the FDA has classified it as Class III.
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-0295-2019
- FDA event ID
- 81644
- Recalling firm
- QuVa Pharma, Sugar Land, TX
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 21 Nov 2018
- FDA classified
- 12 Dec 2018
- Reported
- 19 Dec 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Drug class
- Allergy Medication
Timeline
| 21 Nov 2018 | Recall initiated by company | |
| 12 Dec 2018 | Classified by FDA | +21 days |
| 19 Dec 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect excipient: Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride
Product as listed by the FDA
Norepinephrine 8 mg (32 mcg/mL) added to 0.9% Sodium Chloride Injection 250 mL Bag, Rx only, Compounded by: QuVA Pharma 1075 West Park One Drive Suite 100 Sugar Land, TX 77478. Product Code 70092-9035-05
Where it was distributed
CA only
Questions about this recall
Why was it recalled?
Incorrect excipient: Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride
Which lots are affected?
Lot #:10016014 Exp. 01/06/2019
Where was it sold?
CA only
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
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 Norepinephrine recalls
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | NORepinephrine 4 mg/ added to 0.9% sodium chloride 16 mcg/mL, IV recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS II | norepinephrine, 16 mg, added to dextrose 5%, IV recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS II | Norepinephrine 8mg in 0.9% Sodium Chloride recalled | SCA Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Norepinephrine in 5% Dextrose Injection, 8 mg recalled by SterRx | SterRx | Sterility | Nationwide |
| Drug | CLASS II | Norepinephrine, 4 mg per, (18 mcg per mL) recalled by SterRx | SterRx | Sterility | Nationwide |