Why it was recalled
Subpotent Drug: The product is sub-potent prior to its 90-day beyond use date.
Product description
Cefuroxime, Ophthalmic Solution for Injection, 10 mg/mL, 0.3 mL single-use syringe. This is a Compounded Drug, Hospital & Office Use Only, Not for Resale. Fagron Sterile Services/JCB Laboratories, 7335 W. 33rd St. N., Wichita, KS 67205
Lot numbers, UPCs & expiration codes
Lot #: C274-000002725, BUD 1/21/2018; C274-000002790, BUD 1/28/2018; C274-000002989, BUD 2/13/2018; C274-000003008, BUD 2/14/2018; C274-000003077, BUD 2/20/2018
Where it was sold
Nationwide within 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-0246-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 24, 2018
- FDA report date
- Feb 7, 2018
- Quantity
- 6,510 syriges
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- JCB Laboratories LLC
Original FDA data
Every field from FDA enforcement report D-0246-2018, exactly as published.
Show all FDA fields
- City
- Wichita
- State
- KS
- Status
- Terminated
- Country
- United States
- Event ID
- 78962
- Address
- 7335 W 33rd St N
- Code information
- Lot #: C274-000002725, BUD 1/21/2018; C274-000002790, BUD 1/28/2018; C274-000002989, BUD 2/13/2018; C274-000003008, BUD 2/14/2018; C274-000003077, BUD 2/20/2018
- Postal code
- 67205-9368
- Report date
- Feb 7, 2018
- Product type
- Drugs
- Recall number
- D-0246-2018
- Classification
- Class III
- Recalling firm
- JCB Laboratories LLC
- Product quantity
- 6,510 syriges
- Termination date
- Aug 3, 2020
- Reason for recall
- Subpotent Drug: The product is sub-potent prior to its 90-day beyond use date.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cefuroxime, Ophthalmic Solution for Injection, 10 mg/mL, 0.3 mL single-use syringe. This is a Compounded Drug, Hospital & Office Use Only, Not for Resale. Fagron Sterile Services/JCB Laboratories, 7335 W. 33rd St. N., Wichita, KS 67205
- Distribution pattern
- Nationwide within USA
- Recall initiation date
- Jan 24, 2018
- Initial firm notification
- Letter
- Center classification date
- Jan 30, 2018