Why it was recalled
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Product description
Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-090-42
Lot numbers, UPCs & expiration codes
Lot #:2331104, Exp:9-Mar-24; 2331137, Exp: 3-Mar-24; 2331196, Exp: 11-Mar-24; 2331264, Exp: 6-Apr-24; 2331282, Exp: 18-Apr-24; 2331464, Exp: 8-May-24; 2331481, Exp: 16-May-24; 2331500, Exp: 20-May-24.
Where it was sold
Nationwide in the USA
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-0363-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Feb 20, 2024
- FDA report date
- Mar 6, 2024
- Quantity
- 40,890 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Denver Solutions, LLC DBA Leiters Health
Original FDA data
Every field from FDA enforcement report D-0363-2024, exactly as published.
Show all FDA fields
- City
- Englewood
- State
- CO
- Status
- Ongoing
- Country
- United States
- Event ID
- 94071
- Address
- 13796 Compark Blvd
- Code information
- Lot #:2331104, Exp:9-Mar-24; 2331137, Exp: 3-Mar-24; 2331196, Exp: 11-Mar-24; 2331264, Exp: 6-Apr-24; 2331282, Exp: 18-Apr-24; 2331464, Exp: 8-May-24; 2331481, Exp: 16-May-24; 2331500, Exp: 20-May-24.
- Postal code
- 80112-7145
- Report date
- Mar 6, 2024
- Product type
- Drugs
- Recall number
- D-0363-2024
- Classification
- Class II
- Recalling firm
- Denver Solutions, LLC DBA Leiters Health
- Product quantity
- 40,890 vials
- Reason for recall
- Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-090-42
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Feb 20, 2024
- Initial firm notification
- Letter
- Center classification date
- Feb 29, 2024