Drug product
Cefuroxime 10mg/mL INJ 0.5 mg, SDV, Rx only, Pacific Compounding, Stockton, CA
D-1076-2019
Product summary
- Event
- Event 82477
- Status
- Terminated
- Classification
- Class II
- Quantity
- 41.4 mL
- Official record key
drug-enforcement:D-1076-2019
Official wording
Reason: Presence of Particulate Matter: Particulate matter was reported in one lot of Cefuroxime by a physician after use of product.. FDA analysis identified the particulate as coring of the rubber stopper
Code information: Lot # 07232018@15 BUD 9/6/18 (frozen)
Distribution pattern: California
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter