Milk of Magnesia Recalled for Manufacturing Process Control Issues
Plastikon Healthcare LLC is recalling Milk of Magnesia USP due to manufacturing process control deviations affecting approximately 92,200 cups distributed nationwide.
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 without reported illnesses or injuries. The hazard involves manufacturing process control deviations rather than a specific identified contamination or defect. This is a precautionary regulatory compliance recall with no documented adverse health events.
Plain-English summary
Plastikon Healthcare LLC is recalling Milk of Magnesia USP, 2400 mg/10 mL (magnesium hydroxide), packaged in 30 mL cups, due to manufacturing process control deviations. The affected product was distributed nationwide in the USA and included approximately 92,200 cups across multiple lots with expiration dates ranging from August 2022 through December 2023. The affected lot numbers are 20085A, 20099A, 21039A, 21052A, 21114A, 21130A, and 21132A.
The recall was initiated because the products were manufactured under conditions that did not meet Current Good Manufacturing Practice (CGMP) standards. The manufacturing processes were not adequately controlled, which violates FDA regulations for pharmaceutical production.
This product was intended for institutional use. Institutions and healthcare facilities in possession of the recalled lots should discontinue use immediately and contact Plastikon Healthcare LLC for guidance on proper handling and disposal of the product.
The recalled product
- Product
- MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 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 0904-6840-72.
- Manufacturer
- Plastikon Healthcare LLC
- Category
- Drug — Oral Laxative
- Hazard
- Affected units
- 92,200
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 (12)
- Lot # 20085A
- EXP Aug. 2022
- 20099A
- EXP Oct. 2022
- 21039A
- 21052A
- EXP May. 2023
- 21114A
- EXP Oct. 2023
- 21130A
- 21132A
- EXP Dec. 2023.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 19 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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