Why it was recalled
CGMP DEVIATIONS
Product description
Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-148-94
Lot numbers, UPCs & expiration codes
Lot #: 2231026, Exp. Date 2/23/2023; 2231051, Exp. Date 3/11/2023; 2231156, Exp. Date 5/29/2023; 2231163, Exp. Date 3/26/2023; 223130, Exp. Date 4 5/7/2023; 2231308, Exp. Date 5/11/2023
Where it was sold
Nationwide within the United States including VA or other Government facilities
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-0445-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 21, 2023
- FDA report date
- Mar 15, 2023
- Quantity
- 8,136 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Denver Solutions, LLC DBA Leiters Health
Original FDA data
Every field from FDA enforcement report D-0445-2023, exactly as published.
Show all FDA fields
- City
- Englewood
- State
- CO
- Status
- Terminated
- Country
- United States
- Event ID
- 91762
- Address
- 13796 Compark Blvd
- Code information
- Lot #: 2231026, Exp. Date 2/23/2023; 2231051, Exp. Date 3/11/2023; 2231156, Exp. Date 5/29/2023; 2231163, Exp. Date 3/26/2023; 223130, Exp. Date 4 5/7/2023; 2231308, Exp. Date 5/11/2023
- Postal code
- 80112-7145
- Report date
- Mar 15, 2023
- Product type
- Drugs
- Recall number
- D-0445-2023
- Classification
- Class II
- Recalling firm
- Denver Solutions, LLC DBA Leiters Health
- Product quantity
- 8,136 units
- Termination date
- Jan 11, 2024
- Reason for recall
- CGMP DEVIATIONS
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-148-94
- Distribution pattern
- Nationwide within the United States including VA or other Government facilities
- Recall initiation date
- Feb 21, 2023
- Initial firm notification
- Center classification date
- Mar 7, 2023