Drug product

VANCOMYCIN INTRAVITREAL 1MG/0.1ML SOLUTION, 0.5 mL syringes, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

D-0056-2023

October 07, 2022

Class II

Product summary

Firm: Pharmacy Plus, Inc. dba Vital Care Compounder
Event: Event 90982
Status: Ongoing
Classification: Class II
Quantity: 12 syringes
Official record key: drug-enforcement:D-0056-2023

Official wording

Reason: 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.

Code information: Lots: 65432, BUD: 10/13/2022; 66347, BUD: 11/05/2022; 66864, BUD: 11/18/2022

Distribution pattern: AL, LA, MS, and TN

Derived failure modes

Sterility assurance
reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility