D-0261-2020 Class II Terminated

Recalled by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy — Mesa, AZ

Recall Details

Product Type
Drugs
Report Date
November 13, 2019
Initiation Date
August 12, 2019
Termination Date
April 13, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10 50 ml vials

Product Description

S-EDETATE DISODIUM 15% INJ, packaged in 50ml glass vial, Rx Only, Red Mountain Compounding RX.

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide in the USA

Code Information

Lot #:S07232019DH@14 Exp 8/23/19; S07162019DT@06 Exp 8/16/19; S07172019DT@04 Exp 8/17/19