Ranier's Compounding Laboratory product recalled over sterility concerns

Recall date

July 25, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Ranier's Compounding Laboratory recalls P/P/P 0.02/40/2mg/mL(Prostaglandin//Papaverine/Phentolamine) Injection, 0.02/40/2 mg/mL, 1 mL vial, Rx only, Ranier's R…

Recall number

D-1093-2018

FDA classification

Class II

Brand / firm

Ranier's Compounding Laboratory

Sold / distributed

Product was distributed within the state of Pennsylvania.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

P/P/P 0.02/40/2mg/mL(Prostaglandin//Papaverine/Phentolamine) Injection, 0.02/40/2 mg/mL, 1 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.