Why it was recalled
Labeling: Not Elsewhere Classified
Product description
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
Lot numbers, UPCs & expiration codes
Lot#: 2330956, Exp. 10/23/2023; 2330964, Exp. 10/24/2023; 2331014, Exp. 11/6/2023; 2331033, Exp. 11/8/2023
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0070-2024
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 4, 2023
- FDA report date
- Nov 1, 2023
- Quantity
- 6,276 IV bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Denver Solutions, LLC DBA Leiters Health
Original FDA data
Every field from FDA enforcement report D-0070-2024, exactly as published.
Show all FDA fields
- City
- Englewood
- State
- CO
- Status
- Terminated
- Country
- United States
- Event ID
- 93178
- Address
- 13796 Compark Blvd
- Code information
- Lot#: 2330956, Exp. 10/23/2023; 2330964, Exp. 10/24/2023; 2331014, Exp. 11/6/2023; 2331033, Exp. 11/8/2023
- Postal code
- 80112-7145
- Report date
- Nov 1, 2023
- Product type
- Drugs
- Recall number
- D-0070-2024
- Classification
- Class III
- Recalling firm
- Denver Solutions, LLC DBA Leiters Health
- Product quantity
- 6,276 IV bags
- Termination date
- Aug 15, 2024
- Reason for recall
- Labeling: Not Elsewhere Classified
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Oct 4, 2023
- Initial firm notification
- Letter
- Center classification date
- Oct 26, 2023