Recalls / Class III
Class IIID-0070-2024
Product
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
- Affected lot / code info
- Lot#: 2330956, Exp. 10/23/2023; 2330964, Exp. 10/24/2023; 2331014, Exp. 11/6/2023; 2331033, Exp. 11/8/2023
Why it was recalled
Labeling: Not Elsewhere Classified
Recalling firm
- Firm
- Denver Solutions, LLC DBA Leiters Health
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 13796 Compark Blvd, N/A, Englewood, Colorado 80112-7145
Distribution
- Quantity
- 6,276 IV bags
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2023-10-04
- FDA classified
- 2023-10-26
- Posted by FDA
- 2023-11-01
- Terminated
- 2024-08-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0070-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.