Class II · Moderate risk
Cefuroxime 4mg /0.4 mL
Lack of Assurance of Sterility
Cefuroxime 10mg/mL INJ 0.5 mg
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
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
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
Cefuroxime 10mg/mL INJ 0.5 mg, SDV, Rx only, Pacific Compounding, Stockton, CA
Drug: Cefuroxime
- Recalling firm
- Pacific Compounding Pharmacy & Consultations Inc
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1076-2019 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Cefuroxime recalls
See all
Class II · Moderate risk
CEFUROXIME INTRAVITREAL SYR 1MG/0.1ML Solution in 1 mL syringe
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Class II · Moderate risk
Cefuroxime
Lack of Assurance of Sterility
Class II · Moderate risk
Cefuroxime 10 mg/mL in Sodium Chloride
Incorrect Product Formulation; compounded sterile drug reconstituted using sterile water instead of sterile 0.9% Sodium Chloride.
Class III · Low risk
Cefuroxime
Subpotent Drug: The product is sub-potent prior to its 90-day beyond use date.
Other particulate / foreign matter recalls from 2018
All particulate / foreign matter recalls
Class II · Moderate risk
OZURDEX (dexamethasone intravitreal implant)
GMP Deviations: A silicone particulate was noted in Ozurdex.
Class I · High risk
Ceftriaxone for Injection USP
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Class I · High risk
Ceftriaxone for Injection USP
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Class I · High risk
Ceftriaxone for Injection USP
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.