CLASS III Drug recall · Reported 5 Oct 2022 · FDA Enforcement Report
oxyTOCIN/mL) added to 9% Sodium Chloride, Injection recalled
QuVa Pharma is recalling oxyTOCIN/mL) added to 9% Sodium Chloride, Injection for IV Use, High Alert, This is a, distributed nationwide in the US. The recall was initiated on 20 Sep 2022 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-1544-2022
- FDA event ID
- 90898
- Recalling firm
- QuVa Pharma, Bloomsbury, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 20 Sep 2022
- FDA classified
- 26 Sep 2022
- Reported
- 5 Oct 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Packaging Defects
- Drug class
- Injectable & IV Drugs
Timeline
| 20 Sep 2022 | Recall initiated by company | |
| 26 Sep 2022 | Classified by FDA | +6 days |
| 5 Oct 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of 0.9% Sodium Chloride (500mL).
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride, Injection for IV Use, High Alert, This is a Compounded Product for Institutional or Office Use Only, Not for Resale, QuVa PHARMA 519 Route 173, Bloomsbury, NJ 08804, Total volume: 500 mL bag, NDC: 70092-1068-07.
Where it was distributed
Nationwide in the USA
Questions about this recall
Is oxyTOCIN/mL) added to 9% Sodium Chloride, Injection for IV Use, High Alert, This is a recalled?
Yes. QuVa Pharma recalled oxyTOCIN/mL) added to 9% Sodium Chloride, Injection for IV Use, High Alert, This is a on 20 Sep 2022. The recall is Class III and its status is Terminated. Recall number D-1544-2022.
Why was it recalled?
Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of 0.9% Sodium Chloride (500mL).
Which lots are affected?
Lot 30027403, BUD 11/14/2022
Where was it sold?
Nationwide in the 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 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 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 |