CLASS I Drug recall · Reported 26 Sep 2018 · FDA Enforcement Report
Norepinephrine 4 mg (16 mcg/mL) added to 5% Dextrose Bag recalled
QuVa Pharma is recalling Norepinephrine 4 mg (16 mcg/mL) added to 5% Dextrose Bag Preservative Free, distributed nationwide in the US. The recall was initiated on 27 Aug 2018 and the FDA has classified it as Class I.
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-0003-2019
- FDA event ID
- 80980
- Recalling firm
- QuVa Pharma, Sugar Land, TX
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 27 Aug 2018
- FDA classified
- 1 Oct 2018
- Reported
- 26 Sep 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Potency & Assay
- Drug class
- Allergy Medication
Timeline
| 27 Aug 2018 | Recall initiated by company | |
| 26 Sep 2018 | Published in enforcement report | +30 days |
| 1 Oct 2018 | Classified by FDA | +5 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug: Product may not have the active ingredient present in the bag.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Norepinephrine 4 mg (16 mcg/mL) added to 5% Dextrose 250 mL Bag Preservative Free, Rx only, QuVa Pharma, 519 Route 173, Bloombury, NJ 08804, UPC 70092103417.
Where it was distributed
Nationwide to hospitals in USA
Questions about this recall
Why was it recalled?
Subpotent Drug: Product may not have the active ingredient present in the bag.
Which lots are affected?
Lot #:30000271, Exp 10/1/18
Where was it sold?
Nationwide to hospitals in USA
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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 |