Plastikon Recalls Milk of Magnesia Unit Dose Cups for Microbial Contamination
Plastikon Healthcare LLC is recalling specific lots of Milk of Magnesia unit dose cups because they failed bioburden testing for Total Aerobic Microbial Count.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Plastikon Healthcare LLC is voluntarily recalling 1,433 cases of Milk of Magnesia USP, 2400 mg/30 mL, 30 mL unit dose cups. The affected product is packaged in 100-count cartons of 10 trays x 10 unit dose cups and is labeled for institutional use only. The specific lots involved are 19027D and 19027E, with an expiration date of 07/21.
The recall was initiated because the product failed bioburden testing for Total Aerobic Microbial Count, indicating microbial contamination. The product was distributed nationwide in the USA through one distributor.
Institutional users should check their inventory for the affected lot numbers and stop using the product. Consumers who may have obtained this product should contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Milk of Magnesia USP, 2400 mg/30 mL, Magnesium Hydroxide 2400 mg, 30 mL unit dose cups, For Institutional Use Only, packaged in 100-count cartons of 10 trays x 10 unit dose cups, Major Pharmaceuticals, Livonia, MI 48152, NDC 0904-6846-73.
- Manufacturer
- Plastikon Healthcare LLC
- Hazard
- Affected units
- 1,433
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)
- Lots: 19027D
- 19027E
- Exp 07/21
Distribution
Distributed nationwide across the United States.
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