Drug product

IVME SUPER B INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

D-0121-2022

October 12, 2021

Class II

Product summary

Firm: Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Event: Event 88862
Status: Terminated
Classification: Class II
Quantity: 99 vials
Official record key: drug-enforcement:D-0121-2022

Official wording

Reason: Lack of assurance of sterility

Code information: Lot: 07262021:54 BUD: 10/24/2021; 07262021:04 BUD: 10/24/2021; 09092021:07 BUD: 12/09/2021; 09092021:97 BUD: 12/09/2021; 09102021:10 BUD: 12/09/2021

Distribution pattern: United States including Washington, D.C. and Puerto Rico

Derived failure modes

Sterility assurance
reason.sterility_assurance · v1.0.0

Lack of assurance of sterility