drugs Class II Updated 2014-08-27

Fresenius Kabi USA, LLC recalls PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 mg/mL, 1 mL Singl

Recalled 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

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot 6007698, Exp. 03/16
View official government recall

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