FDA recall D-1019-2013

Product

Glutathione 100 mg/mL Injectable, 100mL Vial, Use as Directed, RX, Creative Compounds, Wilsonville, OR 97070.

Reason for recall

Glutathione 100 mg/mL injectable human drug is recalled due to Out Of Specification results or potential bacterial contamination and it was reported as passing by a contract laboratory.

Distribution

Oregon and Washington

Key facts

Status

Terminated

Initiation date

2013-08-23

Report date

2013-09-18

Termination date

2013-09-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wilsonville, OR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1019-2013