FDA-Drug2014-01-22Class II
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
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.
Sold states
Hospitals, clinics, physicians, and patients in the Michigan area only.
Affected count
a) Injectable 800 mL; b) Topical 600 mL
Manufactured in
350 S Lafayette St, South Lyon, MI, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-458-2014Don't want to check this manually?
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