CLASS III Drug recall · Reported 1 Nov 2023 · FDA Enforcement Report
Oxytocin synthetic added to 0.9% Sodium Chloride IV Bag per mL) recalled
Denver Solutions is recalling Oxytocin synthetic added to 0.9% Sodium Chloride IV Bag per mL), distributed nationwide in the US. The recall was initiated on 4 Oct 2023 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-0070-2024
- FDA event ID
- 93178
- Recalling firm
- Denver Solutions, Englewood, CO
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 4 Oct 2023
- FDA classified
- 26 Oct 2023
- Reported
- 1 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Drug class
- Injectable & IV Drugs
Timeline
| 4 Oct 2023 | Recall initiated by company | |
| 26 Oct 2023 | Classified by FDA | +22 days |
| 1 Nov 2023 | 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
Labeling: Not Elsewhere Classified
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06 Units per mL), Rx only, Leiter Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-157-70
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Labeling: Not Elsewhere Classified
Which lots are affected?
Lot#: 2330956, Exp. 10/23/2023; 2330964, Exp. 10/24/2023; 2331014, Exp. 11/6/2023; 2331033, Exp. 11/8/2023
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 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.
Other products in this recall event
2 other products · FDA event 93178This product is part of a recall event; the main page for the event is VANCOmycin HCI PF added to 0.9% Sodium Chloride IV recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | VANCOmycin HCI PF added to 0.9% Sodium Chloride IV recalled | Denver Solutions | Foreign Material | Nationwide | |
| CLASS III | VANCOmycin HCI PF added to 0.9% Sodium Chloride IV recalled | Denver Solutions | Foreign Material | Nationwide |
More recalls from Denver Solutions
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg recalled | Denver Solutions | Sterility | Nationwide |
| Drug | CLASS II | Ketamine HCl 50mg per (10 mg per mL) Single Dose Syringe recalled | Denver Solutions | Sterility | Nationwide |
| Drug | CLASS II | Glycopyrrolate, 1mg per, (0.2 mg/mL), Single Dose syringe recalled | Denver Solutions | Sterility | Nationwide |
| Drug | CLASS II | dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg recalled | Denver Solutions | Sterility | Nationwide |
| Drug | CLASS II | Rocuronium Bromide 50 mg per (10mg per mL) Single Dose Syringe recalled | Denver Solutions | Sterility | Nationwide |