Why it was recalled
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Product description
PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Item F3352, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-150-82.
Lot numbers, UPCs & expiration codes
Lot #: 2330939, Exp. Date 01/30/2024; 2331032, Exp. Date 02/03/2024; 2331112, Exp. Date 03/19/2024; 2331190, Exp. Date 03/26/2024; 2331429, Exp. Date 04/28/2024.
Where it was sold
Nationwide within the United States
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-0280-2024
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Dec 28, 2023
- FDA report date
- Feb 7, 2024
- Quantity
- 12,564 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-0280-2024, exactly as published.
Show all FDA fields
- City
- Englewood
- State
- CO
- Status
- Ongoing
- Country
- United States
- Event ID
- 93710
- Address
- 13796 Compark Blvd
- Code information
- Lot #: 2330939, Exp. Date 01/30/2024; 2331032, Exp. Date 02/03/2024; 2331112, Exp. Date 03/19/2024; 2331190, Exp. Date 03/26/2024; 2331429, Exp. Date 04/28/2024.
- Postal code
- 80112-7145
- Report date
- Feb 7, 2024
- Product type
- Drugs
- Recall number
- D-0280-2024
- Classification
- Class I
- Recalling firm
- Denver Solutions, LLC DBA Leiters Health
- Product quantity
- 12,564 IV bags
- Reason for recall
- Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Item F3352, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-150-82.
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Dec 28, 2023
- Initial firm notification
- Center classification date
- Jan 29, 2024