Home / Recalls / Plastikon Healthcare LLC / D-0868-2022

D-0868-2022 Class I

Recalled by Plastikon Healthcare LLC — Lawrence, KS

FDA drug recall D-0868-2022 was initiated by Plastikon Healthcare LLC on Mar 24, 2022 and is designated Class I. Reason for recall: Microbial Contamination of Non-Sterile Products Affected quantity: 23,300 Unit Dose cups.

Recall Details

Product Type: Drugs
Report Date: May 25, 2022
Initiation Date: Mar 24, 2022
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 23,300 Unit Dose cups

Product Description

Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distribute by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6838-73.

Reason for Recall

Microbial Contamination of Non-Sterile Products

Distribution Pattern

Distributed in Indiana for further distribution in the USA.

Code Information

Lot: 21067A, EXP Jun 2023

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0868-2022
openFDA file date: Oct 6, 2026
Loaded by RegDataLab: Oct 12, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it. FDA may have changed the recall since.

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