Milk of Magnesia Institutional Units Recalled for Manufacturing Quality Deviation
Plastikon Healthcare LLC is recalling 5,400 unit doses of Milk of Magnesia USP (Lot 20041A, exp. May 2022) due to failure to properly investigate failed microbial testing during manufacturing. The product was distributed in Indiana for further distribution nationwide.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving CGMP deviation with failure to properly investigate failed microbial testing. The recall presents a risk of potential product contamination due to inadequate investigation, but no illnesses or injuries have been reported. The hazard is theoretical pending proper investigation, placing this in the High severity category per the rubric.
Plain-English summary
Plastikon Healthcare LLC, distributed by Major Pharmaceuticals in Livonia, Michigan, is recalling 5,400 unit doses of Milk of Magnesia USP (2400 mg/30 mL) packaged in 30 mL cups. The affected product is Lot 20041A with an expiration date of May 2022.
The recall is due to a Current Good Manufacturing Practice (CGMP) deviation identified during manufacturing. Specifically, the manufacturer failed to properly investigate the results of failed microbial testing, which means the product may not have undergone adequate quality assurance procedures to ensure safety and efficacy.
This product is for institutional use only and was distributed in Indiana for further distribution throughout the United States.
Healthcare facilities and institutional pharmacies that received product from the affected lot should stop use immediately. Return the product to Major Pharmaceuticals or consult the distributor for proper disposition instructions.
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 — Laxative
- Affected units
- 5,400
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 (2)
- Lot: 20041A
- 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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