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D-0870-2022 Class II

Recalled by Plastikon Healthcare LLC — Lawrence, KS

FDA drug recall D-0870-2022 was initiated by Plastikon Healthcare LLC on Mar 24, 2022 and is designated Class II. Reason for recall: CGMP Deviations: Failure to properly investigate failed microbial testing. Affected quantity: 5,400 Unit Dose cups.

Recall Details

Product Type: Drugs
Report Date: May 25, 2022
Initiation Date: Mar 24, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 5,400 Unit Dose cups

Product Description

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.

Reason for Recall

CGMP Deviations: Failure to properly investigate failed microbial testing.

Distribution Pattern

Distributed in Indiana for further distribution in the USA.

Code Information

Lot: 20041A, EXP May 2022

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0870-2022
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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