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

D-1879-2019 Class I Terminated

Recalled by Plastikon Healthcare LLC — Lawrence, KS

Recall Details

Product Type
Drugs
Report Date
September 18, 2019
Initiation Date
August 30, 2019
Termination Date
November 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

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)