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

D-1492-2022 Class II Terminated

Recalled by Plastikon Healthcare LLC — Lawrence, KS

FDA drug recall D-1492-2022 was initiated by Plastikon Healthcare LLC on Jun 7, 2022 and is designated Class II. Reason for recall: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. The recall status is terminated (terminated Jun 25, 2025). Affected quantity: 7,200 ampoules.

Recall details

Product Type: Drugs
Report Date: Sep 14, 2022
Initiation Date: Jun 7, 2022
Termination Date: Jun 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

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1492-2022
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 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)