Home / Recalls / Plastikon Healthcare LLC / D-0870-2022

D-0870-2022 Class II

Recalled by Plastikon Healthcare LLC — Lawrence, KS

Recall Details

Product Type: Drugs
Report Date: May 25, 2022
Initiation Date: March 24, 2022
Termination Date: N/A
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

Other recalls by Plastikon Healthcare LLC

D-1486-2022 Class II — Acetaminophen Oral Solution 650 mg / 20.3 mL, 20.3 mL cup, packaged in 10 cups p (June 7, 2022)
D-1490-2022 Class II — GUAIFENESIN AND DEXTROMETHORPHAN 100 mg-10 mg/5 mL, 5 mL cup, packaged in 10 cup (June 7, 2022)
D-1481-2022 Class II — MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged in (June 7, 2022)
D-1476-2022 Class I — MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged in (June 7, 2022)
D-1479-2022 Class I — Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, (June 7, 2022)
D-1491-2022 Class II — GUAIFENESIN AND DEXTROMETHORPHAN 200-20 mg/10 mL, 10 mL cup, packaged in 10 cups (June 7, 2022)
D-1488-2022 Class II — Diphenhydramine HCl Oral Solution 12.5 mg / 5 mL, 5 mL cup, packaged in 10 cups (June 7, 2022)
D-1485-2022 Class II — Acetaminophen Oral Solution, 325 mg / 10.15 mL, 10.15 mL cup, packaged in 10 cup (June 7, 2022)
D-1482-2022 Class II — Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per (June 7, 2022)
D-1483-2022 Class II — Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, (June 7, 2022)