Fresenius Kabi USA, LLC recalls PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 mg/mL, 1 mL Single Dose Vial, Rx only, APP Pharmaceuticals, LLC Schaumburg, I
Recalled August 27, 2014 · FDA recall D-1545-2014 · Fresenius Kabi USA
Hazard
CGMP Deviations: Citations given to API supplier by the Italian Health Agency AIFA for several critical deficiencies which caused a recall of the API lot used to manufacture Propanolo HCl Injection. · FDA Class II
Units
56,060 vials
Sold at
Nationwide and Puerto Rico
Description
CGMP Deviations: Citations given to API supplier by the Italian Health Agency AIFA for several critical deficiencies which caused a recall of the API lot used to manufacture Propanolo HCl Injection.
Product
PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 mg/mL, 1 mL Single Dose Vial, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-604-01
Manufacturer(s)
Fresenius Kabi USA, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →