FDA recall D-1083-2018

Product

Triple P (Prostaglandin/Papaverine/Phentolamine) Injection, 0.008/22.5/0.83 mg/mL, packaged in a) 5 mL and b) 10 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-1083-2018