Lidocaine and Phenylephrine Injectable Vials Recalled for Glass Delamination
Denver Solutions is recalling Lidocaine-Phenylephrine injectable vials nationwide due to glass delamination in the vials. The defect could potentially introduce glass fragments into the medication.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (injectable medication potentially contaminated with glass fragments) where no injuries have been reported, placing it in the High category per the severity rubric.
Plain-English summary
Denver Solutions, LLC, operating as Leiters Health, is recalling Lidocaine HCL 1% (10 mg/mL) and Phenylephrine HCL 1.5% (15 mg/mL) injectable single-dose vials nationwide. The product is prescribed by healthcare providers for various medical applications.
The recall was initiated because the glass vials show signs of glass delamination, which can result in glass particles contaminating the medication within the vial. If glass particles are present in a vial and injected, they could potentially cause harm.
Healthcare providers and pharmacies that have these vials should discontinue use immediately. The affected vials have NDC 71449-090-42 and include the following lot numbers: 2331104 (exp. March 9, 2024), 2331137 (exp. March 3, 2024), 2331196 (exp. March 11, 2024), 2331264 (exp. April 6, 2024), 2331282 (exp. April 18, 2024), 2331464 (exp. May 8, 2024), 2331481 (exp. May 16, 2024), and 2331500 (exp. May 20, 2024). Those who have received injections from affected vials should consult their healthcare provider about any concerns.
The recalled product
- Product
- 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
- Manufacturer
- Denver Solutions, LLC DBA Leiters Health
- Category
- Drug — Injectable
- Affected units
- 40,890
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- 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.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Denver Solutions, LLC DBA Leiters Health under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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