D-0026-2023 Class II Ongoing

Recalled by Pharmacy Plus, Inc. dba Vital Care Compounder — Hattiesburg, MS

Recall Details

Product Type
Drugs
Report Date
November 9, 2022
Initiation Date
October 7, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1 droptainer

Product Description

ACETYLCYSTEINE OPTH 10% Solution, 15 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

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.

Distribution Pattern

AL, LA, MS, and TN

Code Information

Lot: 66895, BUD: 11/19/2022