FDA Recall D-1479-2022
Plastikon Healthcare LLC · Lawrence, KS
Class I — life-threatening Terminated 1114 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral Suspension, 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 0904-6839-73
Reason for recall
Microbial Contamination of Non-Sterile Products.
Recall record
- Recall number
D-1479-2022- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- Distributed Nationwide in the USA
- Recall initiated
- 2022-06-07
- Classified by FDA Center
- 2022-09-06
- FDA published
- 2022-09-14
- Terminated
- 2025-06-25
- Recalling firm
- Plastikon Healthcare LLC
- Firm location
- Lawrence, KS