D-1483-2022 Class II Terminated
FDA drug recall D-1483-2022 was initiated by Plastikon Healthcare LLC on June 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 June 25, 2025). Affected quantity: 88,500 cups.
Recall Details
- Product Type
- Drugs
- Report Date
- September 14, 2022
- Initiation Date
- June 7, 2022
- Termination Date
- June 25, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 88,500 cups
Product Description
Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral Suspension, 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 0904-6839-73
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 # 20084A, 20086A, EXP Aug. 2022; 21074A, 21077A, EXP Jul. 2023