Recalls / Class III
Class IIID-0307-2021
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
- Affected lot / code info
- Lot #: 10-2020-13@8, exp. date 12/03/2020
Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date
Recalling firm
- Firm
- Edge Pharma, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 856 Hercules Dr, N/A, Colchester, Vermont 05446-8014
Distribution
- Quantity
- 60 syringes
- Distribution pattern
- PA only
Timeline
- Recall initiated
- 2020-12-22
- FDA classified
- 2021-03-18
- Posted by FDA
- 2021-03-24
- Terminated
- 2021-06-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0307-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.