FDA recall D-0084-2020

Product

Phenylephrine HCl 1.5% (15 mg/mL) Lidocaine HCl 1% (10 mg/mL) (PF) (Sulfite Free) Ophthalmic Injection, 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678441

Reason for recall

Lack of Assurance of Sterility

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2019-09-12

Report date

2019-10-09

Termination date

2021-08-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Boca Raton, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0084-2020