Specialty Medicine Compounding Pharmacy recalls 0.9% Sodium chloride a) DT-0.9% Sodium chloride* 100 mL Drug Study - IV 100 mL Injectable, b) DT-0.9% Sodium Chloride* 1
Recalled January 22, 2014 · FDA recall D-458-2014 · Specialty Medicine Compounding Pharmacy
Hazard
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. · FDA Class II
Units
a) Injectable 800 mL; b) Topical 600 mL
Sold at
Hospitals, clinics, physicians, and patients in the Michigan area only.
Description
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Product
0.9% Sodium chloride a) DT-0.9% Sodium chloride* 100 mL Drug Study - IV 100 mL Injectable, b) DT-0.9% Sodium Chloride* 100 mL Drug Study - Topical, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Manufacturer(s)
Specialty Medicine Compounding Pharmacy
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →