Drug product
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
D-0246-2018
Product summary
- Event
- Event 78962
- Status
- Terminated
- Classification
- Class III
- Quantity
- 6,510 syriges
- Official record key
drug-enforcement:D-0246-2018
Official wording
Reason: Subpotent Drug: The product is sub-potent prior to its 90-day beyond use date.
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
Distribution pattern: Nationwide within USA
Derived failure modes
-
Potency or specification failure
Subpotent