Recalls / Class II
Class IID-1482-2022
Product
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
- Affected lot / code info
- 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
Why it was recalled
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Recalling firm
- Firm
- Plastikon Healthcare LLC
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 3780 Greenway Cir, N/A, Lawrence, Kansas 66046-5440
Distribution
- Quantity
- 521,700 cups
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2022-06-07
- FDA classified
- 2022-09-06
- Posted by FDA
- 2022-09-14
- Terminated
- 2025-06-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1482-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.