Cefuroxime 10mg/mL INJ 0.5 mg, SDV, Rx only, Pacific Compounding, Stockton, CA

FDA recall notice · announced April 10, 2019 · Pacific Compounding Pharmacy & Consultations

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Cefuroxime 10mg/mL INJ 0.5 mg, SDV, Rx only, Pacific Compounding, Stockton, CA

Reason for recall

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

Notes

Distribution: California
Lot/code information: Lot # 07232018@15 BUD 9/6/18 (frozen)
Quantity: 41.4 mL
Status: Terminated
Products in this recall event:
- Cefuroxime 10mg/mL INJ 0.5 mg, SDV, Rx only, Pacific Compounding, Stockton, CA (D-1076-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.