Milk of Magnesia USP Recalled for Microbial Contamination
Plastikon Healthcare LLC is recalling Milk of Magnesia USP (2400 mg/30 mL) distributed in Indiana due to microbial contamination in this non-sterile product. The FDA classified this as a Class I recall.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, the highest priority pharmaceutical classification, which requires a minimum severity score of 4 per the rubric rules. Class I recalls are issued for the most serious safety issues in drug products.
Plain-English summary
Plastikon Healthcare LLC is recalling Milk of Magnesia USP (Magnesium Hydroxide), 2400 mg/30 mL, distributed for institutional use. The recall affects 14,100 unit-dose cups distributed in Indiana for further distribution throughout the United States.
The FDA classified this as a Class I recall due to microbial contamination in the non-sterile product formulation. Class I recalls represent the most serious type of pharmaceutical safety action.
Institutions and distributors that received product bearing lot numbers 20024A or 20025A with expiration date March 2022 are affected. Affected parties should immediately stop use and distribution of these lots.
For more information and instructions on handling affected product, contact the distributor Major Pharmaceuticals (Livonia, MI) or the manufacturer Plastikon Healthcare LLC.
The recalled product
- Product
- MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 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 0904-6846-73.
- Manufacturer
- Plastikon Healthcare LLC
- Category
- Drug
- Hazard
- Affected units
- 14,100
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 (3)
- Lot: 20024A
- 20025A
- EXP Mar 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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