D-1076-2019 Class II Terminated

Recalled by Pacific Compounding Pharmacy & Consultations Inc — Stockton, CA

Recall Details

Product Type
Drugs
Report Date
April 10, 2019
Initiation Date
August 23, 2018
Termination Date
April 27, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
41.4 mL

Product Description

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

Distribution Pattern

California

Code Information

Lot # 07232018@15 BUD 9/6/18 (frozen)