Recalls / Class I
Class ID-0868-2022
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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, Distribute by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6838-73.
- Affected lot / code info
- Lot: 21067A, EXP Jun 2023
Why it was recalled
Microbial Contamination of Non-Sterile Products
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
- 23,300 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-0868-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.