Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral Suspension, 30 mL cup, p
Summary
The FDA issued a Class II for Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, by Plastikon Healthcare LLC. Reason: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled..
Details
Source
Drug Recall
External ID
D-1483-2022
Action Date
2022-09-14
Status
Terminated
Category
drug
Product Description
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
Lot/Code Info: Lot # 20084A, 20086A, EXP Aug. 2022; 21074A, 21077A, EXP Jul. 2023
Quantity Affected: 88,500 cups
Reason for Recall
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Distribution
Distributed Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-07
Company
Lawrence, KS
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
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 II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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-1483-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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