Glutathione 200mg/mL, 10mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. ...
FDA Recall #D-0638-2018 — Class II — March 22, 2018
Product Description
Glutathione 200mg/mL, 10mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Recalling Firm
Partell Specialty Pharmacy — Las Vegas, NV
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
four vials
Distribution
NV only
Code Information
Lot#: 20180219@58, BUD 05/20/2018; 20180131@15, BUD 05/01/2018; 20180116@9, BUD 04/14/2018; 20180103@5, BUD 04/03/2018.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated