Why it was recalled
Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
Product description
Ceftazidime Sterile Ophthalmic Solution for Injection Preservative Free 11.25mg / 0.5ml (22.5mg/ml) 0.5ml per syringe. KEEP FROZEN UNTIL USE AND PROTECT FROM LIGHT SINGLE USE SYRINGE FOR INTRAOCULAR INJECTION Edge Pharma, LLC is an FDA-registered 503B outsourcing facility. This is a compounded (re-packaged) drug. Not for Resale, Hospital/Office use only. Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178
Lot numbers, UPCs & expiration codes
Lot # 02-2020-04@4
Where it was sold
Distributed Nationwide in the USA
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-0238-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 19, 2020
- FDA report date
- Jan 27, 2021
- Quantity
- 48 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Edge Pharma, LLC
Original FDA data
Every field from FDA enforcement report D-0238-2021, exactly as published.
Show all FDA fields
- City
- Colchester
- State
- VT
- Status
- Terminated
- Country
- United States
- Event ID
- 87135
- Address
- 856 Hercules Dr
- Code information
- Lot # 02-2020-04@4
- Postal code
- 05446-8014
- Report date
- Jan 27, 2021
- Product type
- Drugs
- Recall number
- D-0238-2021
- Classification
- Class II
- Recalling firm
- Edge Pharma, LLC
- Product quantity
- 48 syringes
- Termination date
- Jun 7, 2023
- Reason for recall
- Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ceftazidime Sterile Ophthalmic Solution for Injection Preservative Free 11.25mg / 0.5ml (22.5mg/ml) 0.5ml per syringe. KEEP FROZEN UNTIL USE AND PROTECT FROM LIGHT SINGLE USE SYRINGE FOR INTRAOCULAR INJECTION Edge Pharma, LLC is an FDA-registered 503B outsourcing facility. This is a compounded (re-packaged) drug. Not for Resale, Hospital/Office use only. Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Mar 19, 2020
- Initial firm notification
- Letter
- Center classification date
- Jan 19, 2021