Home / Recalls / Plastikon Healthcare LLC / D-1492-2022

D-1492-2022 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
7,200 ampoules

Product Description

CORRECTDOSE Children's ALLERGY RELIEF (Diphenhydramine HCl 12.5 mg per 5 mL), 2.04 FL. OZ (60 mL) packaged in 12- 5mL individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-302-05 UPC 8 60003 67144 3

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 # 21011A, EXP Jan. 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)