Home / Recalls / Plastikon Healthcare LLC / D-1494-2022

D-1494-2022 Class II Terminated

Recalled by Plastikon Healthcare LLC — Lawrence, KS

FDA drug recall D-1494-2022 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: 1,464 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: 1,464 ampoules

Product description

CORRECTDOSE Children's COUGH & CHEST CONGESTION DM (Guaifenesin 100 mg / Dextromethorphan 5 mg per 5 mL) 2.04FL. OZ (60mL), packaged in 12-5 individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-321-05 UPC 8 60003 67146 7

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 # 21014A, EXP Feb. 2023

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1494-2022
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.

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