Recalls / Class II
Class IID-0871-2022
Product
Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6838-73.
- Affected lot / code info
- Lot: 20042A, 20043A, 20045A, 20046A, 20047A, EXP May 2022
Why it was recalled
CGMP Deviations: Failure to properly investigate failed microbial testing.
Recalling firm
- Firm
- Plastikon Healthcare LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 3780 Greenway Cir, N/A, Lawrence, Kansas 66046-5440
Distribution
- Quantity
- 106,400 Unit Dose cups
- Distribution pattern
- Distributed in Indiana for further distribution in the USA.
Timeline
- Recall initiated
- 2022-03-24
- FDA classified
- 2022-05-13
- Posted by FDA
- 2022-05-25
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0871-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.