Skip to content
Recall Observatory FDA recall evidence

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

D-1545-2014

August 13, 2014

Class II

Product summary

Firm
Fresenius Kabi USA, LLC
Event
Event 68910
Status
Terminated
Classification
Class II
Quantity
56,060 vials
Official record key
drug-enforcement:D-1545-2014

Official wording

Reason: 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.

Code information: Lot 6007698, Exp. 03/16

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations