Antacid Suspension Recalled Due to Manufacturing Process Control Deviations
Plastikon Healthcare LLC is recalling multiple lots of antacid suspension because manufacturing processes were not adequately controlled. The product was distributed nationwide to institutions.
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 with CGMP deviations and no reported illnesses, injuries, or deaths. This is a precautionary manufacturing compliance recall without evidence of harm.
Plain-English summary
Plastikon Healthcare LLC is recalling its Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, and Simethicone 120 mg per 30 mL oral suspension. The product is supplied in 30 mL cups, packaged 10 cups per tray, for institutional use only, under NDC 0904-6838-73.
The recall is due to Current Good Manufacturing Practice (CGMP) deviations. Products were manufactured under conditions in which manufacturing processes were not adequately controlled.
Approximately 521,700 cups were distributed nationwide throughout the United States. The affected lots include multiple lot numbers with expiration dates ranging from August 2022 through January 2024.
The recalled product
- Product
- 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
- Manufacturer
- Plastikon Healthcare LLC
- Category
- Drug — Antacid
- Hazard
- manufacturing-process-deviation
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 (20)
- Lot # 20077A
- 20080A
- 20082A
- EXP Aug. 2022
- 21016A
- EXP Feb. 2023
- 21026A
- EXP Mar. 2023
- 21042A
- 21047A
- 21050A
- EXP Apr. 2023
- 21057A
- 21059A
- 21060A
- EXP May. 2023
- 21061A
- 21067A
- 21070A
- 21072A
Distribution
Distributed nationwide across the United States.
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