FDA recall D-0335-2015

Product

Glutathione 200 mg/mL Injectable, packaged in a) 5 mL MDV (multiple dose vials), b) 30 mL MDV (multiple dose vials), and c) 100 mL MDV (multiple dose vials), Rx only, Carie Boyd's Prescription Shop, 122 Grapevine Highway, Hurst, TX 76054, (817) 282-9376.

Reason for recall

Incorrect Product Formulation: An incorrect gas was used to remove the oxygen from the vial.

Distribution

KS, MO, and TX.

Key facts

Status

Terminated

Initiation date

2014-12-12

Report date

2015-01-14

Termination date

2016-11-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hurst, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0335-2015