CLASS II Drug recall · Reported 17 Jun 2020 · FDA Enforcement Report
oxyTOCIN/mL) added to 9% Sodium Chloride Injection for IV Use recalled
QuVa Pharma is recalling oxyTOCIN/mL) added to 9% Sodium Chloride Injection for IV Use, distributed nationwide in the US. The recall was initiated on 28 May 2020 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-1302-2020
- FDA event ID
- 85773
- Recalling firm
- QuVa Pharma, Sugar Land, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 May 2020
- FDA classified
- 11 Jun 2020
- Reported
- 17 Jun 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 28 May 2020 | Recall initiated by company | |
| 11 Jun 2020 | Classified by FDA | +14 days |
| 17 Jun 2020 | Published in enforcement report | +6 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 did not contain drug.
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
oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride Injection for IV Use, Rx only, QuVa Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 888-339-0874, NDC 70092-1068-07
Where it was distributed
USA Nationwide
Questions about this recall
Is oxyTOCIN/mL) added to 9% Sodium Chloride Injection for IV Use recalled?
Yes. QuVa Pharma recalled oxyTOCIN/mL) added to 9% Sodium Chloride Injection for IV Use on 28 May 2020. The recall is Class II and its status is Terminated. Recall number D-1302-2020.
Why was it recalled?
Subpotent drug - Product did not contain drug.
Which lots are affected?
Lot#: 30010515
Where was it sold?
USA 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.
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|---|---|---|---|---|---|
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