Axium Healthcare Pharmacy dba Balanced Solutions Compounding: Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.; Lack of Sterility Assurance

Agency: Food and Drug Administration (FDA)

Event ID: 64957

Status: Resolved

Manufacturer: Axium Healthcare Pharmacy dba Balanced Solutions Compounding

Manufactured In: United States

Units Affected: 24 products (380 vials (5 mL and 10 mL vials); 326 vials (10 mL each); 286 vials (30 mL vials each); 401 vials (10 mL vials each); 28 vials (10 mL each); 15 vials ((30 mL each); 29 vials (9 mL and 30 mL); 11 vials (10 mL each); 12 vials (15 mL each); 5 vials (3 mL each); 10 vials (30 mL each); 15 vials (10 mL each); 61 vials (5 mL and 10 mL vials); 6 vials (5 mL and 10 mL each); 3 vials (10 mL vials); 4 vials (5 mL each); 3 vials (10 mL each); 2 50 mL vials; 172 vials (5 mL vials each); 18 viasl (10 mL each); 1 vial (10 mL); 5 vials (30 mL each); 1 vial (10 mL); 1 vial (15 mL))