Recalls / Class II
Class IID-1480-2022
Product
MILK OF MAGNESIA USP, 2400 mg/30 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 0904-6846-73.
- Affected lot / code info
- Lot # 20072A, 20075A, EXP Jul. 2022; 20087A, EXP Aug. 2022; 20089A, 20090A, EXP Sep. 2022; 20100A, 20102A, EXP Oct. 2022; 20106A, 20107A EXP Nov. 2022; 20109A, EXP Dec. 2022; 21010A, EXP Jan. 2023; 21028A, 21030A, 21032A, EXP Mar. 2023; 21045A, 21046A, EXP Apr. 2023; 21054A, EXP May. 2023; 21078A, 21079A, 21085A, EXP Jul. 2023; 21088A, EXP Aug. 2023
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
- 502,600 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-1480-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.