D-1481-2022 Class II Terminated
FDA drug recall D-1481-2022 was initiated by Plastikon Healthcare LLC on Jun 7, 2022 and is designated Class II. Reason for recall: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. The recall status is terminated (terminated Jun 25, 2025). Affected quantity: 92,200 cups.
Recall details
- Product Type
- Drugs
- Report Date
- Sep 14, 2022
- Initiation Date
- Jun 7, 2022
- Termination Date
- Jun 25, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 92,200 cups
Product description
MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6840-72.
Reason for recall
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Distribution pattern
Distributed Nationwide in the USA
Code information
Lot # 20085A, EXP Aug. 2022; 20099A, EXP Oct. 2022; 21039A, 21052A, EXP May. 2023; 21114A, EXP Oct. 2023; 21130A, 21132A, EXP Dec. 2023.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1481-2022
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026