Home / Recalls / Plastikon Healthcare LLC / D-0871-2022

D-0871-2022 Class II

Recalled by Plastikon Healthcare LLC — Lawrence, KS

FDA drug recall D-0871-2022 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: 106,400 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: 106,400 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, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6838-73.

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: 20042A, 20043A, 20045A, 20046A, 20047A, 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-0871-2022
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.

Other recalls by Plastikon Healthcare LLC

D-1482-2022 Class II — Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per… (Jun 7, 2022)
D-1486-2022 Class II — Acetaminophen Oral Solution 650 mg / 20.3 mL, 20.3 mL cup, packaged in 10 cups… (Jun 7, 2022)
D-1490-2022 Class II — GUAIFENESIN AND DEXTROMETHORPHAN 100 mg-10 mg/5 mL, 5 mL cup, packaged in 10… (Jun 7, 2022)
D-1481-2022 Class II — MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged in… (Jun 7, 2022)
D-1476-2022 Class I — MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged in… (Jun 7, 2022)
D-1479-2022 Class I — Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX… (Jun 7, 2022)
D-1491-2022 Class II — GUAIFENESIN AND DEXTROMETHORPHAN 200-20 mg/10 mL, 10 mL cup, packaged in 10 cups… (Jun 7, 2022)
D-1488-2022 Class II — Diphenhydramine HCl Oral Solution 12.5 mg / 5 mL, 5 mL cup, packaged in 10 cups… (Jun 7, 2022)
D-1485-2022 Class II — Acetaminophen Oral Solution, 325 mg / 10.15 mL, 10.15 mL cup, packaged in 10… (Jun 7, 2022)
D-1480-2022 Class II — MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged in… (Jun 7, 2022)