CLASS III Drug recall · Reported 24 Mar 2021 · FDA Enforcement Report
Epinephrine/Lidocaine HCl, Sterile Ophthalmic Solution recalled
Edge Pharma is recalling Epinephrine/Lidocaine HCl, Sterile Ophthalmic Solution for Injection per syringe, Single, distributed in Pennsylvania. The recall was initiated on 22 Dec 2020 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0307-2021
- FDA event ID
- 87514
- Recalling firm
- Edge Pharma, Colchester, VT
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 22 Dec 2020
- FDA classified
- 18 Mar 2021
- Reported
- 24 Mar 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Pain Medication
Timeline
| 22 Dec 2020 | Recall initiated by company | |
| 18 Mar 2021 | Classified by FDA | +86 days |
| 24 Mar 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp Date
Product as listed by the FDA
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
Where it was distributed
PA only
Questions about this recall
Why was it recalled?
Labeling: Incorrect or Missing Lot and/or Exp Date
Which lots are affected?
Lot #: 10-2020-13@8, exp. date 12/03/2020
Where was it sold?
PA only
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Edge Pharma
All 62| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Phenylephrine HCl, Sterile Solution for Injection, (PF) recalled | Edge Pharma | Sterility | Nationwide |
| Drug | CLASS II | Tetracaine HCl Nasal Solution recalled by Edge Pharma | Edge Pharma | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Methotrexate, USP, Sterile Solution for Injection (PF) recalled | Edge Pharma | Sterility | Nationwide |
| Drug | CLASS II | CSF Otic Insufflation Capsule recalled by Edge Pharma | Edge Pharma | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Ceftazidime, Sterile Ophthalmic Solution for Injection recalled | Edge Pharma | Sterility | Nationwide |
Other Epinephrine recalls
All 35| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Epinephrine Injection, USP, 1mg/mL single-dose vial recalledEpinephrine | Fresenius Kabi USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Epinephrine Injection, USP, 1 mg/ (0.1 mg/mL) recalledEpinephrine | International Medication Systems | Sterility | Nationwide |
| Drug | CLASS II | Adrenalin (epinephrine) Injection 1mg/mL single dose vial recalledAdrenalin | Henry Schein Inc. and Glove Club HSI Gloves | Packaging Defects | Nationwide |
| Drug | CLASS II | EPINEPHrine, 2 mg added to dextrose 5%, Concentration = 8 mcg/mL, IV recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS II | EPINEPHrine 8mg/ added to dextrose 5%, 32 mcg/mL, IV recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |