FDA recall D-1545-2014

Fresenius Kabi USA, LLC · Class II · drug

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.

Distribution

Nationwide and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2014-08-13
Report date: 2014-08-27
Termination date: 2016-05-24
Voluntary/Mandated: Voluntary: Firm initiated
Location: Melrose Park, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1545-2014