SB-6 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 60 mcg/mL recalled over sterility concerns

Recall date

May 9, 2022

Source

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

Official notice title

Olympia Compounding Pharmacy dba Olympia Pharmacy recalls SB-6 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 60 mcg/mL, Packaged in a) 5 mL Multi-Dose vial, NDC 73198-0025-05; b)…

Recall number

D-0901-2022

FDA classification

Class II

Brand / firm

Olympia Compounding Pharmacy dba Olympia Pharmacy

Sold / distributed

Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands

Why it was recalled

Lack of assurance of sterility.

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

What was recalled

SB-6 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 60 mcg/mL, Packaged in a) 5 mL Multi-Dose vial, NDC 73198-0025-05; b) 10 mL, Multi-Dose vial, NDC 73198-0025-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835