Drug Enforcement D-0040-2023

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.

1 Views

Status

Ongoing

Classification

Class II

Report Date

November 9, 2022

Termination Date

Product Information

Product description
MOXIFLOXACIN PRESERVATIVE FREE SYR, 0.15 mg/0.1 mL, Sterile Solution, 1 mL syringes, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Product quantity
106 syringes
Reason for recall
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.
Recall initiation reason
Initial firm notification
Telephone
Distribution pattern
AL, LA, MS, and TN

Location & Firm

Recalling firm
Pharmacy Plus, Inc. dba Vital Care Compounder
Address
115 S 40th Ave, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-0040-2023
Event ID
90982
Recall initiation date
October 7, 2022
Center classification date
November 2, 2022
Code info
Lot: 66470, BUD: 11/10/2022
More code info