Drug product

MIC-B12+B6 Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1579-2015

June 02, 2015

Class II

Product summary

Firm: The Compounding Pharmacy of America
Event: Event 71371
Status: Terminated
Classification: Class II
Quantity: 473 ml total
Official record key: drug-enforcement:D-1579-2015

Official wording

Reason: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information: All lots distributed between November 2014 and May 2015; 02232015@93, 5/24/2015; 03132015@21, 6/11/2015, 04062015@38, 7/5/2015; 04082015@17, 7/7/2015; 04272015@83, 7/26/2015

Distribution pattern: Nationwide

Derived failure modes

Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

GMP violations
Sterility assurance
reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility