FDA recall D-1479-2022

Plastikon Healthcare LLC · Class I · drug

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.

Distribution

Distributed Nationwide in the USA

Key facts

Status
Terminated
Initiation date
2022-06-07
Report date
2022-09-14
Termination date
2025-06-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lawrence, KS, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1479-2022