AT-6 Papaverine 40 mg/mL Phentolamine 4 mg/mL Atropine 0 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 AT-6 Papaverine 40 mg/mL Phentolamine 4 mg/mL Atropine 0.3 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceutica…

Recall number

D-0919-2022

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

AT-6 Papaverine 40 mg/mL Phentolamine 4 mg/mL Atropine 0.3 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835 NDC 73198-0040-10