Isomeric Pharmacy Solution product recalled over sterility concerns

Recall date

April 6, 2017

Source

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

Official notice title

Isomeric Pharmacy Solution, LLC recalls Cyanocobalamin 1 mg/mL/ Methionine 25 mg/mL/ Inositol 50 mg/mL/ Choline 50 mg/mL, 30 mL Multi-Dose Vial For Injection,…

Recall number

D-0685-2017

FDA classification

Class II

Brand / firm

Isomeric Pharmacy Solution, LLC

Sold / distributed

Nationwide in the USA and Puerto Rico

Why it was recalled

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure 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

Cyanocobalamin 1 mg/mL/ Methionine 25 mg/mL/ Inositol 50 mg/mL/ Choline 50 mg/mL, 30 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1101, barcode 3 70285 11013 9.