Medications & Supplements/Prescription Drugs

Leiters Health Sterile Injectable Vials Recalled for Glass Delamination

Agency Publication Date: February 29, 2024

Summary

Denver Solutions, LLC, doing business as Leiters Health, is recalling approximately 91,000 vials of three sterile injectable medications: Moxifloxacin PF, Moxifloxacin, and a Lidocaine/Phenylephrine combination. The recall was issued because glass vials from the manufacturer showed signs of delamination, a process where the inner surface of the glass vial separates and creates visible or microscopic particles. These medications are used in clinical settings, including for eye surgeries and as local anesthetics.

Risk

The presence of glass particulate matter in injectable medication can cause serious health complications. If injected, these particles can trigger inflammation, irritation, or potentially damage blood vessels and vital organs.

What You Should Do

This recall affects Moxifloxacin PF (1mg/ml), Moxifloxacin (5mg/ml), and Lidocaine HCL (1%)/Phenylephrine HCL (1.5%) sterile injectable medications sold under the Leiters Health brand in single-dose vials.
Identify your product by checking the NDC numbers 71449-096-42, 71449-097-42, and 71449-090-42, along with the lot numbers and expiration dates printed on the vial or carton.
Because this recall includes numerous distinct lot numbers, see the Affected Products section below for the full list of affected codes.
Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Moxifloxacin PF in Sterile Balanced Salt Solution (BSS) (1mg/ml)

Variants: 1mg/ml, Sterile injection, Single-Dose Vial

Lot Numbers:

2331147 (Exp: 6-Mar-24)

2331180 (Exp: 21-Mar-24)

2331256 (Exp: 2-Apr-24)

2331279 (Exp: 3-Apr-24)

2331283 (Exp: 7-Apr-24)

2331345 (Exp: 20-Apr-24)

2331422 (Exp: 27-Apr-24)

2331563 (Exp: 29-May-24)

NDC:

71449-096-42

Intracameral Use Only

Product: Moxifloxacin (5mg/ml)

Variants: 5mg/ml, 1 ml Single-Dose Vial

Lot Numbers:

2331123 (Exp: 28-Feb-24)

2331298 (Exp: 24-Mar-24)

NDC:

71449-097-42

Rx Only

Product: Lidocaine HCL 1% and Phenylephrine HCL 1.5%

Variants: 10mg/mL Lidocaine HCL, 15mg/mL Phenylephrine HCL, 1 ml Single-Dose Vial

Lot Numbers:

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)

NDC:

71449-090-42

RX Only

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94071

Status: Active

Manufacturer: Denver Solutions, LLC DBA Leiters Health

Sold By: Hospitals; Surgical Centers; Infusion Centers; Wholesale Distributors

Manufactured In: United States

Units Affected: 3 products (40,090 vials; 10,020 vials; 40,890 vials)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Moxifloxacin PF (1mg/ml), Moxifloxacin (5mg/ml), and Lidocaine HCL (1%)/Phenylephrine HCL (1.5%) sterile injectable medications sold under the Leiters Health brand in single-dose vials.

Identify your product by checking the NDC numbers 71449-096-42, 71449-097-42, and 71449-090-42, along with the lot numbers and expiration dates printed on the vial or carton.

Because this recall includes numerous distinct lot numbers, see the Affected Products section below for the full list of affected codes.

Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Affected Products

Product: Moxifloxacin PF in Sterile Balanced Salt Solution (BSS) (1mg/ml)

Variants: 1mg/ml, Sterile injection, Single-Dose Vial

Lot Numbers:

2331147 (Exp: 6-Mar-24)

2331180 (Exp: 21-Mar-24)

2331256 (Exp: 2-Apr-24)

2331279 (Exp: 3-Apr-24)

2331283 (Exp: 7-Apr-24)

2331345 (Exp: 20-Apr-24)

2331422 (Exp: 27-Apr-24)

2331563 (Exp: 29-May-24)

NDC:

71449-096-42

Intracameral Use Only

Product: Moxifloxacin (5mg/ml)

Variants: 5mg/ml, 1 ml Single-Dose Vial

Lot Numbers:

2331123 (Exp: 28-Feb-24)

2331298 (Exp: 24-Mar-24)

NDC:

71449-097-42

Rx Only

Product: Lidocaine HCL 1% and Phenylephrine HCL 1.5%

Variants: 10mg/mL Lidocaine HCL, 15mg/mL Phenylephrine HCL, 1 ml Single-Dose Vial

Lot Numbers:

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)

NDC:

71449-090-42

RX Only

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94071

Status: Active

Manufacturer: Denver Solutions, LLC DBA Leiters Health

Sold By: Hospitals; Surgical Centers; Infusion Centers; Wholesale Distributors

Manufactured In: United States

Units Affected: 3 products (40,090 vials; 10,020 vials; 40,890 vials)

Distributed To: Nationwide