FDA recall D-0307-2021

Edge Pharma, LLC · Class III · drug

Product

Epinephrine/Lidocaine HCl, Sterile Ophthalmic Solution for Injection, 0.8 mL per syringe, Single Use Syringe, 0.025%/0.75%, Rx only, Edge Pharma LLC 856 Hercules Dr. Colchester, VT 05446, NDC 05446-0863-01

Reason for recall

Labeling: Incorrect or Missing Lot and/or Exp Date

Distribution

PA only

Key facts

Status
Terminated
Initiation date
2020-12-22
Report date
2021-03-24
Termination date
2021-06-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Colchester, VT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0307-2021