FDA recall D-1086-2018

Ranier's Compounding Laboratory · Class II · drug

Product

Dehydrated Alcohol Solution, packaged in a) 1 mL and b) 3 mL vials, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

Reason for recall

Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.

Distribution

Product was distributed within the state of Pennsylvania.

Key facts

Status
Terminated
Initiation date
2018-07-25
Report date
2018-08-22
Termination date
2022-09-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Jeannette, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1086-2018