FDA Drug recall 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, Ma…
- FDA Drug
- Class II
- terminated
- Published 2022-09-14
On 2022-09-14 the FDA classified a Class II recall of 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, Ma… by Plastikon Healthcare, citing CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1487-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-06-07 |
| Published | 2022-09-14 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Plastikon Healthcare |
| Distribution | US |
Product
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
Reason
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Identifiers
| code_info | Lot # 21021A, 21023A, 21024A, EXP Feb. 2023; 21064A, EXP Jun. 2023; 21073A, 21075A, EXP Jul. 2023; 21100A, EXP Sep. 202…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1487-2022%22
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