CLASS II Drug recall · Reported 10 Apr 2019 · FDA Enforcement Report
Cefuroxime 10mg/mL INJ 0.5 mg, SDV recalled
Pacific Compounding Pharmacy & Consultations is recalling Cefuroxime 10mg/mL INJ 0.5 mg, SDV, distributed in California. The recall was initiated on 23 Aug 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1076-2019
- FDA event ID
- 82477
- Recalling firm
- Pacific Compounding Pharmacy & Consultations, Stockton, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Aug 2018
- FDA classified
- 2 Apr 2019
- Reported
- 10 Apr 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Particulate Matter
- Drug class
- Compounded Drugs
Timeline
| 23 Aug 2018 | Recall initiated by company | |
| 2 Apr 2019 | Classified by FDA | +222 days |
| 10 Apr 2019 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
Cefuroxime 10mg/mL INJ 0.5 mg, SDV, Rx only, Pacific Compounding, Stockton, CA
Where it was distributed
California
Questions about this recall
Why was it 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
Which lots are affected?
Lot # 07232018@15 BUD 9/6/18 (frozen)
Where was it sold?
California
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Cefuroxime recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cefuroxime 4mg / (10 mg/mL) syringe recalled by Pine Pharmaceuticals | Pine Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Cefuroxime, Sterile Ophthalmic Solution for Injection recalled | Edge Pharma | Sterility | Nationwide |
| Drug | CLASS II | Cefuroxime 10 mg/mL in Sodium Chloride recalled by Leiter's Enterprises | Leiter's Enterprises | Sterility | 4 states |
| Drug | CLASS III | Cefuroxime, Ophthalmic Solution for Injection recalled | JCB Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Cefuroxime Sodium 10 mg/mL in 0.9% Sodium Chloride recalled | Leiter's Compounding | Sterility | Nationwide |