CALCIUM CARBONATE ORAL SUSPENSION recalled over manufacturing violations

Recall date

June 7, 2022

Source

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

Official notice title

Plastikon Healthcare LLC recalls CALCIUM CARBONATE ORAL SUSPENSION, 1250 mg/5 mL, 5 mL cup, packaged in 10 cups per tray, 4 trays per carton, For Instit…

Recall number

D-1487-2022

FDA classification

Class II

Brand / firm

Plastikon Healthcare LLC

Sold / distributed

Distributed Nationwide in the USA

Why it was recalled

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

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

What was recalled

CALCIUM CARBONATE ORAL SUSPENSION, 1250 mg/5 mL, 5 mL cup, packaged in 10 cups per tray, 4 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-7098-94