Why it was recalled
Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5 mg/mL
Product description
Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, 10 vials/carton, Rx only, Leiters 13796 Compark Blvd, Englewood, CO 80112, (800) 292-6772, NDC 71449-096-42
Lot numbers, UPCs & expiration codes
Lot #: 2130958; Expiration Date 03/31/2022
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-0288-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 29, 2021
- FDA report date
- Dec 29, 2021
- Quantity
- 1440 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Denver Solutions, LLC DBA Leiters Health
Original FDA data
Every field from FDA enforcement report D-0288-2022, exactly as published.
Show all FDA fields
- City
- Englewood
- State
- CO
- Status
- Terminated
- Country
- United States
- Event ID
- 89136
- Address
- 13796 Compark Blvd
- Code information
- Lot #: 2130958; Expiration Date 03/31/2022
- Postal code
- 80112-7145
- Report date
- Dec 29, 2021
- Product type
- Drugs
- Recall number
- D-0288-2022
- Classification
- Class II
- Recalling firm
- Denver Solutions, LLC DBA Leiters Health
- Product quantity
- 1440 vials
- Termination date
- Jul 12, 2022
- Reason for recall
- Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5 mg/mL
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, 10 vials/carton, Rx only, Leiters 13796 Compark Blvd, Englewood, CO 80112, (800) 292-6772, NDC 71449-096-42
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Nov 29, 2021
- Initial firm notification
- Telephone
- Center classification date
- Dec 17, 2021