Antacid Suspension Recalled for Failed Microbial Testing
Plastikon Healthcare LLC is recalling antacid suspension due to manufacturing quality control failures. The company failed to properly investigate results from microbial testing.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 quality control failures without confirmed contamination or reported illnesses or injuries. The hazard is theoretical and precautionary in nature.
Plain-English summary
Plastikon Healthcare LLC is recalling 106,400 Unit Dose cups of Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, and Simethicone 120mg antacid suspension. The product is distributed by Major Pharmaceuticals for institutional use only.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the manufacturer failed to properly investigate results from failed microbial testing, which is a required quality control function.
The affected product was distributed in Indiana for further distribution throughout the United States. Affected lot numbers are 20042A, 20043A, 20045A, 20046A, and 20047A, all expiring May 2022.
Healthcare facilities should discontinue use of the recalled product. No illnesses or injuries related to this recall have been reported. Patients and healthcare providers with questions should contact Major Pharmaceuticals or the manufacturer.
The recalled product
- Product
- Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6838-73.
- Manufacturer
- Plastikon Healthcare LLC
- Category
- Drug — Antacid
- Hazard
- Affected units
- 106,400
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: 20042A
- 20043A
- 20045A
- 20046A
- 20047A
- EXP May 2022
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 5 recalled by Plastikon Healthcare LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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