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 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-148-94.
Lot numbers, UPCs & expiration codes
Lot #: 2330993, Exp. Date 02/15/2024; 2331010, Exp. Date 02/10/2024; 2331055, Exp. Date 01/18/2024; 2331113, Exp. Date 02/26/2024; 2331181, Exp. Date 03/04/2024; 2331187, Exp. Date 03/23/2024; 2331266, Exp. Date 03/31/2024; 2331343, Exp. Date 04/01/2024; 2331349, Exp. Date 04/23/2024; 2331433, Exp. Date 05/05/2024.
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-0279-2024
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Dec 28, 2023
- FDA report date
- Feb 7, 2024
- Quantity
- 29,016 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-0279-2024, 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 #: 2330993, Exp. Date 02/15/2024; 2331010, Exp. Date 02/10/2024; 2331055, Exp. Date 01/18/2024; 2331113, Exp. Date 02/26/2024; 2331181, Exp. Date 03/04/2024; 2331187, Exp. Date 03/23/2024; 2331266, Exp. Date 03/31/2024; 2331343, Exp. Date 04/01/2024; 2331349, Exp. Date 04/23/2024; 2331433, Exp. Date 05/05/2024.
- Postal code
- 80112-7145
- Report date
- Feb 7, 2024
- Product type
- Drugs
- Recall number
- D-0279-2024
- Classification
- Class I
- Recalling firm
- Denver Solutions, LLC DBA Leiters Health
- Product quantity
- 29,016 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 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-148-94.
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Dec 28, 2023
- Initial firm notification
- Center classification date
- Jan 29, 2024