FDA-Drug2014-08-13Class II
Glutathione Injection USP, 200 mg/ml, packaged in 30 ml vials, Sterile, For IM of Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
Medical Supply Liquidators Llc
Hazard
Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer
Sold states
Nationwide and Foriegn distribution was made to Canada, United Kingdom, Australia, Slovenia, Germany, Spain, Finland and Croatia.
Affected count
N/A
Manufactured in
10500 Hickman Rd Ste F, N/A, Clive, IA, United States
Products
Glutathione Injection USP, 200 mg/ml, packaged in 30 ml vials, Sterile, For IM of Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1533-2014Don't want to check this manually?
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