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
D-0307-2021
Product summary
- Firm
- Edge Pharma, LLC
- Event
- Event 87514
- Status
- Terminated
- Classification
- Class III
- Quantity
- 60 syringes
- Official record key
drug-enforcement:D-0307-2021
Official wording
Reason: Labeling: Incorrect or Missing Lot and/or Exp Date
Code information: Lot #: 10-2020-13@8, exp. date 12/03/2020
Distribution pattern: PA only
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing