Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: 10-2020-13@8, exp. date 12/03/2020
Where it was sold
PA only
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0307-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 22, 2020
- FDA report date
- Mar 24, 2021
- Quantity
- 60 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Edge Pharma, LLC
Original FDA data
Every field from FDA enforcement report D-0307-2021, exactly as published.
Show all FDA fields
- City
- Colchester
- State
- VT
- Status
- Terminated
- Country
- United States
- Event ID
- 87514
- Address
- 856 Hercules Dr
- Code information
- Lot #: 10-2020-13@8, exp. date 12/03/2020
- Postal code
- 05446-8014
- Report date
- Mar 24, 2021
- Product type
- Drugs
- Recall number
- D-0307-2021
- Classification
- Class III
- Recalling firm
- Edge Pharma, LLC
- Product quantity
- 60 syringes
- Termination date
- Jun 10, 2021
- Reason for recall
- Labeling: Incorrect or Missing Lot and/or Exp Date
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- PA only
- Recall initiation date
- Dec 22, 2020
- Initial firm notification
- Letter
- Center classification date
- Mar 18, 2021