Magnesium Hydroxide and Aluminum Hydroxide Oral Suspension Recalled for Manufacturing Control Issues
Plastikon Healthcare LLC is recalling an antacid oral suspension due to manufacturing control deviations. No illnesses have been reported.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall for manufacturing process control deviations (CGMP non-compliance) with no reported illnesses or injuries. The hazard is theoretical, making this a voluntary precautionary recall.
Plain-English summary
Plastikon Healthcare LLC is recalling approximately 88,500 cups of Magnesium Hydroxide/Aluminum Hydroxide/Simethicone oral suspension distributed nationwide for institutional use. The recall was initiated because the products were manufactured under conditions that did not adequately control manufacturing processes, violating current good manufacturing practice (CGMP) requirements.
The affected lots are 20084A and 20086A (expiring August 2022), and 21074A and 21077A (expiring July 2023). These products were distributed nationwide for institutional use only.
Healthcare facilities and institutions that have this product should cease use and distribution. Contact Plastikon Healthcare LLC immediately if you have received affected lots. No illnesses or injuries related to this product have been reported.
The recalled product
- 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
- Manufacturer
- Plastikon Healthcare LLC
- Category
- Drug
- Hazard
- manufacturing-control-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot # 20084A
- 20086A
- EXP Aug. 2022
- 21074A
- 21077A
- EXP Jul. 2023
Distribution
Distributed nationwide across the United States.
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