Drug recall: Norepinephrine 4 mg (16 mcg/mL) added to 5% Dextrose 250 mL Bag Preservative Free, Rx only, QuVa Pharma, 519 Route…

Class I FDA enforcement event 80980. Recall start date: 27 Aug 2018. Status in the FDA record: Terminated. Termination date: 2 Apr 2019.

Reason for recall, in the words of FDA

Subpotent Drug: Product may not have the active ingredient present in the bag.

Class I, in the words of FDA

a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death

QuVa Pharma, Inc. started this drug recall on 27 Aug 2018. The firm address in the FDA record is in Sugar Land, TX. FDA put the recall in Class I. FDA event 80980 has 1 product record. The first FDA enforcement report date is 26 Sep 2018. The record gives the status Terminated, with the termination date 2 Apr 2019.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide to hospitals in USA

Recalling firm

QuVa Pharma, Inc., Sugar Land, TX.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 80980: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0003-2019	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.	528 bags	Class I	Terminated	26 Sep 2018

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class I: The highest of the three FDA recall classes.

The event in context

Drug events that started in 2018: 367
Share of these events in Class I: 11%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 10

Other events of the firm

Other FDA enforcement events of QuVa Pharma, Inc.
Initiated	Product (first record)	Type	Class	Records
24 Jun 2026	Methohexital Sodium, 100 mg/10 mL (10 mg/mL), Total Volume: 10 mL, Rx only, Compounded drug, QuVa Pharma, 1075 W Park On	Drug	Class II	1
10 Oct 2025	R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Tromethamine) in Sodium Chloride Solution, Total Vo	Drug	Class II	1
6 Mar 2025	fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/100 mL (1 mg/mL), 100 ml in NS Yellow CADD FS	Drug	Class II	3
20 Sep 2022	oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride, Injection for IV Use, High Alert, This is a Comp	Drug	Class III	1
28 May 2020	oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride Injection for IV Use, Rx only, QuVa Pharma 1075 W	Drug	Class II	1
23 Apr 2020	R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride solution 50 mL in 60 mL Syringe, Compounded	Drug	Class III	1
12 Nov 2019	fentaNYL 500 mcg/250 mL (2 mcg/mL) Bupivacaine HCl 0.1% 250 mg/250 mL (1 mg/mL) in 0.9% Sodium Chloride 250 mL Bag, Rx o	Drug	Class II	27
21 Nov 2018	Norepinephrine 8 mg (32 mcg/mL) added to 0.9% Sodium Chloride Injection 250 mL Bag, Rx only, Compounded by: QuVA Pharma	Drug	Class III	1
30 Mar 2016	PHENYLephrine 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL syringe, packaged in 24 syringes per case, Rx only,	Drug	Class I	1

QuVa Pharma, Inc.: all 10 events

Official channels

FDA enforcement report D-0003-2019The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 80980. https://recallregister.com/fda/i/80980/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide to hospitals in USA
What quantity of product is in FDA event 80980?: The FDA record gives this quantity: 528 bags
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2018 have the same class?: 11% of the 367 drug events that started in 2018 are in Class I.