D-1482-2022 Class II Terminated
FDA drug recall D-1482-2022 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: 521,700 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
- 521,700 cups
Product Description
Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 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 0904-6838-73
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 # 20077A, 20080A, 20082A, EXP Aug. 2022; 21016A, EXP Feb. 2023; 21026A, EXP Mar. 2023; 21042A, 21047A, 21050A, EXP Apr. 2023; 21057A, 21059A, 21060A,EXP May. 2023; 21061A, 21067A, 21070A, 21072A, EXP Jun. 2023; 21095A, 21097A, 21099A, EXP Sep. 2023; 21107A, 21109A, 21111A, 21113A, EXP Oct. 2023; 21138A, EXP Dec. 2023; 22002A, 22004A, 22005A, EXP Jan. 2024