Why it was recalled
Lack of Assurance of Sterility: Leaking/damaged syringes.
Product description
dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg (base) per mL), 5mL Single Dose syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112, NDC: 71449-131-11.
Lot numbers, UPCs & expiration codes
Lot #: 2431276A, Exp.: 4/20/2025
Where it was sold
Nationwide in the U.S.A
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-0371-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 31, 2025
- FDA report date
- Apr 30, 2025
- Quantity
- 23,610 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Denver Solutions, LLC DBA Leiters Health
Original FDA data
Every field from FDA enforcement report D-0371-2025, exactly as published.
Show all FDA fields
- City
- Englewood
- State
- CO
- Status
- Ongoing
- Country
- United States
- Event ID
- 96607
- Address
- 13796 Compark Blvd
- Code information
- Lot #: 2431276A, Exp.: 4/20/2025
- Postal code
- 80112-7145
- Report date
- Apr 30, 2025
- Product type
- Drugs
- Recall number
- D-0371-2025
- Classification
- Class II
- Recalling firm
- Denver Solutions, LLC DBA Leiters Health
- Product quantity
- 23,610 syringes
- Reason for recall
- Lack of Assurance of Sterility: Leaking/damaged syringes.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg (base) per mL), 5mL Single Dose syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112, NDC: 71449-131-11.
- Distribution pattern
- Nationwide in the U.S.A
- Recall initiation date
- Mar 31, 2025
- Initial firm notification
- Letter
- Center classification date
- Apr 18, 2025