RecallRadar

FDA Drug recall D-0307-2021

Epinephrine/Lidocaine HCl, Sterile Ophthalmic Solution for Injection, 0.8 mL per syringe, Single Use Syringe, 0.025%/0.75%, Rx only, Edge P…

On 2021-03-24 the FDA classified a Class III recall of Epinephrine/Lidocaine HCl, Sterile Ophthalmic Solution for Injection, 0.8 mL per syringe, Single Use Syringe, 0.025%/0.75%, Rx only, Edge P… by Edge Pharma, citing labeling: Incorrect or Missing Lot and/or Exp Date.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0307-2021
ClassificationClass III
Statusterminated
Initiated2020-12-22
Published2021-03-24
Last updated2026-09-13 11:52 UTC
CompanyEdge Pharma
DistributionPA

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

Labeling: Incorrect or Missing Lot and/or Exp Date

Identifiers

code_infoLot #: 10-2020-13@8, exp. date 12/03/2020

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0307-2021%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.