Drug recall D-1545-2014

Class II Terminated reported Aug 27, 2014

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

Reason for recall

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.

Lots and codes

Lot 6007698, Exp. 03/16

Recall details

Recalling firm
Fresenius Kabi USA, LLC, Melrose Park, IL
Quantity
56,060 vials
Distribution
Nationwide and Puerto Rico
Type
Voluntary: Firm initiated
Recall initiated
August 13, 2014
Terminated
May 24, 2016

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