San Jose, CA, United States
Leiter's Enterprises, Inc. recalls
1 recall recorded since 2018, most recently on 19 February 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Drugs
- Recall started
- 19 February 2019
- Terminated
- 26 February 2020
- Reason
- Incorrect Product Formulation; compounded sterile drug reconstituted using sterile water instead of sterile 0.9% Sodium Chloride.
- Distribution
- CA, AZ, MI, NY
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0518-2019
- Cefuroxime 10 mg/mL in Sodium Chloride, Intravitreal injection, 1 mL in a 2mL Vial, Ophthalmic Use Only, Office Use Only, Leiter's (800) 292-6772- 17 Great Oaks Blvd., San Jose, CA 95119. NDC: 70360-007-35.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.