August 2018 FDA Recall Drug by Pacific Compounding Pharmacy & Consultations Inc
D-1076-2019 - Presence of Particulate Matter
This Class II drug recall was voluntarily initiated by Pacific Compounding Pharmacy & Consultations Inc on August 23, 2018 for the product Drug. The FDA reported the reason for recall as presence of particulate matter. The product was distributed in California and the recall is currently terminated.
Recall Number: D-1076-2019
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
08-23-2018
04-10-2019
41.4 mL
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Pacific Compounding Pharmacy & Consultations Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
California
04-27-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Cefuroxime 10mg/mL INJ 0.5 mg, SDV, Rx only, Pacific Compounding, Stockton, CA
Batch or Lot Expiration Information
Lot# 07232018@15 BUD 9/6/18 (frozen)
