FDA Recall D-0868-2022
Plastikon Healthcare LLC · Lawrence, KS
Class I — life-threatening Completed 1512 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence 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.
Reason for recall
Microbial Contamination of Non-Sterile Products
Recall record
- Recall number
D-0868-2022- Classification
- Class I
- Status
- Completed
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Distributed in Indiana for further distribution in the USA.
- Recall initiated
- 2022-03-24
- Classified by FDA Center
- 2022-05-13
- FDA published
- 2022-05-25
- Recalling firm
- Plastikon Healthcare LLC
- Firm location
- Lawrence, KS