FDA recall D-358-2013

Product

Dexpanthenol Injection, all strengths and all presentations including Dexpanthenol 250 mg/30 mL; Dexpanthenol 250 mg/mL 10 mL, 30 mL, 50 mL; and Dexpanthenol 250 mg/mL 10 mL P.F.; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Reason for recall

Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-04-10

Report date

2013-05-22

Termination date

2014-03-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Henderson, NV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-358-2013