Home / Recalls / Plastikon Healthcare LLC / D-1879-2019

D-1879-2019 Class I Terminated

Recalled by Plastikon Healthcare LLC — Lawrence, KS

FDA drug recall D-1879-2019 was initiated by Plastikon Healthcare LLC on Aug 30, 2019 and is designated Class I. Reason for recall: Microbial Contamination of Non-Sterile Products: product failed bioburden testing for Total Aerobic Microbial Count. The recall status is terminated (terminated Nov 4, 2020). Affected quantity: 1,433 cases.

Recall details

Product Type: Drugs
Report Date: Sep 18, 2019
Initiation Date: Aug 30, 2019
Termination Date: Nov 4, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1,433 cases

Product description

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.

Reason for recall

Microbial Contamination of Non-Sterile Products: product failed bioburden testing for Total Aerobic Microbial Count.

Distribution pattern

One distributor who further distributed Nationwide in the USA.

Code information

Lots: 19027D, 19027E, Exp 07/21

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1879-2019
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

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

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