Home / Recalls / Plastikon Healthcare LLC / D-1489-2022

D-1489-2022 Class II Terminated

Recalled by Plastikon Healthcare LLC — Lawrence, KS

Recall Details

Product Type
Drugs
Report Date
September 14, 2022
Initiation Date
June 7, 2022
Termination Date
June 25, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
349,100 cups

Product Description

Diphenhydramine HCl Oral Solution, 25 mg / 10 mL, 10 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6741-72

Reason for Recall

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Distribution Pattern

Distributed Nationwide in the USA

Code Information

Lot # 20065A, EXP Jun. 2022; 20068A, 20070A, EXP Jul. 2022; 20097A, 20098A, EXP Oct. 2022; 21055A, EXP May. 2023; 21083A, EXP Jul. 2023; 21091A, EXP Aug. 2023; 21112A, EXP Oct. 2023

Other recalls by Plastikon Healthcare LLC

  • 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-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-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-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-1484-2022 Class II — Acetaminophen Oral Solution 160 mg / 5 mL, 5 mL cup, packaged in 10 cups per tra (June 7, 2022)