FDA recall D-1156-2014

Product

Dextrose* Vial In Sterile Water, 50%, 50 mL Single Dose Vial, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Reason for recall

Non-Sterility: 50% dextrose is being recalled after particulate matter, later identified as mold, was found floating in the product.

Distribution

Hospitals, clinics, physicians, and patients in the Michigan area only.

Key facts

Status

Terminated

Initiation date

2013-10-19

Report date

2014-03-19

Termination date

2014-09-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

South Lyon, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1156-2014