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FDAFDA · Food and drugs·Recall number D-1487-2022

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

Published September 14, 2022 · Recall initiated: June 7, 2022

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recall details

Manufacturer
Plastikon Healthcare LLC
Distributor
Distributed Nationwide in the USA
Lot
Lot # 21021A, 21023A, 21024A, EXP Feb. 2023; 21064A, EXP Jun. 2023; 21073A, 21075A, EXP Jul. 2023; 21100A, EXP Sep. 2023; 21118A, 21120A, EXP Nov. 2023; 21128A, 21129A, 21131A, 21135A, EXP Dec. 2023; 22019A, EXP Mar. 2024.
Risk classification
Class II
Area (FDA)
drug
Country
United States

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