Class II
Terminated
PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 mg/mL, 1 mL Single Dose Vial, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-604-01
- Company
- Fresenius Kabi Usa, Llc
- Recall Initiated
- August 13, 2014
- Posted
- August 27, 2014
- Recall Number
- D-1545-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 56,060 vials
- Firm Location
- Melrose Park, IL, United States
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
Lot / Code Info
Lot 6007698, Exp. 03/16
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