Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 mL cup, packaged in 10 cups pe
Summary
The FDA issued a Class I for Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per by Plastikon Healthcare LLC. Reason: Microbial Contamination of Non-Sterile Products..
Details
Source
Drug Recall
External ID
D-1478-2022
Action Date
2022-09-14
Status
Terminated
Category
drug
Product Description
Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 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 0904-6838-73
Lot/Code Info: Lot# 20076A, EXP Jul. 2022, 20079A, 20081A, EXP Aug. 2022; 21096A, EXP Oct. 2022; 21115A, 21103A, EXP Sep. 2022.
Quantity Affected: 220,500 cups
Reason for Recall
Microbial Contamination of Non-Sterile Products.
Distribution
Distributed Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-07
Company
Lawrence, KS
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 47 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Plastikon Healthcare LLC has 24 FDA actions in our database, including 24 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Plastikon Healthcare LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Plastikon Healthcare LLC have FDA actions?
Plastikon Healthcare LLC has 24 FDA actions in our database, including 24 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1478-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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